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Found 8 results
510(k) Data Aggregation
K Number
K242956Device Name
LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle
Manufacturer
OcuJect, LLC
Date Cleared
2024-10-25
(30 days)
Product Code
QNS, FMI, QYM
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
OcuJect, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LDS Needle is intended for use with a luer-tip syringe for the administration of drugs.
The OcuSafe® LDS Needle is intended for use with a luer-tip syringe for the administration of drugs. The OcuSafe® LDS Needle is indicated for intravitreal use.
The SteriCap® LDS Safety Needle is intended for use with a luer-tip syringe for the administration of drugs. The SteriCap Safety Needle has an integrated passive needle cap/shield that covers the needle prior to use and automatically activates to cover the needle immediately after use. A lock mechanism can be manually activated to lock'unlock the needle cap. The locked needle cap minimizes risk of accidental needle stick.
The VitreJect® LDS Safety Needle is intended for use with a luer-tip syringe for the administration of drugs. The VitreJect® LDS Safety Needle has an integrated passive needle cap/shield that covers the needle prior to use and automatically activates to cover the needle immediately after use. A lock mechanism can be manually activated to lock/unlock the needle cap. The locked needle cap minimizes risk of accidental needle stick. The VitreJect® LDS Safety Needle is indicated for intravitreal use.
Device Description
The LDS Needle / OcuSafe® LDS Needle / VitreJect® LDS Safety Needle / SteriCap® LDS Safety Needle are designed to provide a means of fluid injection and aspiration. The devices are single-lumen needles intended for use with a luer-tip syringe. The Low Dead Space (LDS) needle has a decreased internal volume within the luer taper to reduce fluid volume loss. The LDS Needle and OcuSafe® LDS Needle have a removable cap that is removed prior to the needle's use. The SteriCap® LDS Safety Needle and VitreJect® LDS Safety Needle have a spring-actuated, non-removable sliding cap that protects the needle prior and during its use. They are intended for use by health care professionals for administration of drugs. Their operation is manual. The LDS Needle / OcuSafe® LDS Needle / VitreJect® LDS Needle / SteriCap® LDS Needle are single use only, non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The VitreJect® LDS Safety Needle and OcuSafe® LDS Needle are suitable for intravitreal use.
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K Number
K233343Device Name
SteriCap Safety Needle; VitreJect Safety Needle
Manufacturer
OcuJect, LLC
Date Cleared
2023-11-27
(59 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
OcuJect, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SteriCap Safety Needle is intended for use with a luer-tip syringe for the administration of drugs. The SteriCap Safety Needle has an integrated passive needle shield that covers the needle prior to use and automatically activates to cover the needle immediately after use. A lock mechanism can be manually activated to lock/unlock the needle shield. The locked needle shield minimizes risk of accidental needle stick.
The VitreJect Safety Needle is intended for use with a luer-tip syringe for the administration of drugs. The VitreJect Safety Needle is indicated for intravitreal use.
The VitreJect Safety Needle has an integrated passive needle shield that covers the needle prior to use and automatically activates to cover the needle immediately after use. A lock mechanism can be manually activated to lock/unlock the needle shield. The locked needle shield minimizes risk of accidental needle stick.
Device Description
The SteriCap Safety Needle is designed to provide a means of fluid injection and aspiration to and from the body. It is a single lumen hypodermic needle intended for use with a luer-tip syringe. The SteriCap Safety Needle has a spring-actuated, non-removable sliding cap that moves along the axis of the needle hub during clinical use and automatically re-covers the needle tip after use. The needle cap can be manually locked/unlocked. The SteriCap Safety Needle is intended for manual use by health care professionals for administration of drugs. The SteriCap Safety Needle is single use only, non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas.
The VitreJect Safety Needle is designed to provide a means of fluid injection and aspiration to and from the body. It is a single lumen hypodermic needle intended for use with a luer-tip syringe. The VitreJect Safety Needle has a spring-actuated, non-removable sliding cap that moves along the axis of the needle hub during clinical use and automatically re-covers the needle tip after use. The needle cap can be manually locked/unlocked. The VitreJect Safety Needle is intended for manual use by health care professionals for administration of drugs. The VitreJect Safety Needle is single use only, non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The VitreJect Safety Needle is suitable for ophthalmic use.
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K Number
K230959Device Name
VitreJect® Needle; OcuSafe® Needle
Manufacturer
OcuJect, LLC
Date Cleared
2023-09-14
(163 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
OcuJect, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vitrelect® Needle is intended for use with a luer-tip syringe for the administration of drugs. The VitreJect® Needle is indicated for intravitreal use.
The OcuSafe® Needle is intended for use with a luer-tip syringe for the administration of drugs. The OcuSafe® Needle is indicated for intravitreal use.
Device Description
The VitreJect® / OcuSafe® Needles are designed to provide a means of fluid injection and aspiration. The devices are single-lumen needles intended for use with a luer-tip syringe. The VitreJect® Needle has a spring-actuated, non-removable sliding cap that protects the needle prior and during its use. The OcuSafe® Needle has a removable cap that is removed prior to the needle's use. They are intended for use by health care professionals for administration of drugs. Their operation is manual. The VitreJect®/OcuSafe® Needles are single use only, non-toxic, nonpyrogenic, and sterilized by ethylene oxide gas. The VitreJect®/OcuSafe® Needles are suitable for ophthalmic use.
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K Number
K230372Device Name
VitreJect Syringe
Manufacturer
OcuJect, LLC
Date Cleared
2023-09-08
(207 days)
Product Code
QLY, FMF, QNQ
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
OcuJect, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VitreJect Syringe is intended to inject fluids into, or withdraw fluids from, the body. The VitreJect Syringe is indicated for intracameral and intravitreal use.
Device Description
The Vitrelect Syringe is designed to provide a means of fluid injection and aspiration. It is a luer-tip piston syringe consisting of a 1 mL hollow barrel with gradient markings and a plunger with an incorporated plunger stopper. The VitreJect Syringe barrel component is available in two configurations, a luer-slip or luer-lock tip, for the fitting of a compatible hypodermic needle. The VitreJect Syringe plunger is available in two configurations: standard dead space or low dead space. It is intended for manual use by health care professionals. The VitreJect Syringe is single use only, non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The VitreJect Syringe is suitable for ophthalmic use.
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K Number
K212544Device Name
MiniLoad Syringe
Manufacturer
OcuJect, LLC
Date Cleared
2021-10-13
(62 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
OcuJect, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MiniLoad Syringe is used to facilitate injections into or withdraw fluids from the body.
Device Description
The MiniLoad Syringe is a device intended to provide a means of fluid injection and aspiration. The device is comprised of a hollow barrel with gradient markings and a plunger. The barrel component is available in two configurations: 1) with a male slip tip end 2) with a luer-lock end; both for the fitting of a compatible needle. The device is available in a 1ml volume.
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K Number
K212805Device Name
SteriCap Mini Needle and Standard Needles
Manufacturer
OcuJect, LLC
Date Cleared
2021-09-30
(28 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
OcuJect, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SteriCap™ Mini Needle and standard needles are intended for use with a luer-tip syringe (e.g. luer-lock or slip-ip luer syringe) for the administration of drugs.
Device Description
The SteriCap® Mini Needle ("SteriCap®") and Needles ("Needles") are devices intended to provide a means of fluid injection and aspiration to and from the body. The devices are a single lumen needle. For SteriCap® Mini Needle, the needle has a spring-actuated sliding cap, which protects the needle prior to use. For Needles, the needle is covered by a removable clear cap.
The additional gauges and lengths of the product family included in this submission are 30G/31G/33Gx 6mm and 31G / 33G x 4 mm. The additional gauges and lengths of the Needle included in this submission are 29G/30G/31G x 13 mm and 33G x 8 mm.
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K Number
K202432Device Name
MiniLoad Syringe
Manufacturer
OcuJect, LLC
Date Cleared
2021-02-19
(178 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
OcuJect, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MiniLoad Syringe is used to facilitate injections into or withdraw fluids from the body.
Device Description
The MiniLoad Syringe is a device intended to provide a means of general use fluid injection and aspiration. The device is comprised of a hollow barrel with gradient markings and a plunger. The barrel component has a male slip tip end for the fitting of a compatible needle. The device is available in a 1ml volume.
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K Number
K170768Device Name
Mini Needle
Manufacturer
OcuJect, LLC
Date Cleared
2017-07-10
(118 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
OcuJect, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mini Needle is intended for use with a luer-tip syringe (e.g. luer-lock or slip-tip luer syringe) for the administration of drugs into the body.
Device Description
The Mini Needle is a device intended to provide a means of fluid delivery into the human body via body surface puncture. The device is a single lumen needle available in 30G, 32G and 33G sizes with a 5.5mm exposed length. The distal end of the needle has a spring-loaded needle cap, which shields the needle prior to use.
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