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Found 5 results
510(k) Data Aggregation
K Number
K201699Device Name
Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor
Manufacturer
Surgical Instrument and Savings Inc (dba Medline ReNewal)
Date Cleared
2020-07-22
(30 days)
Product Code
NLF
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
Surgical Instrument and Savings Inc (dba Medline ReNewal)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor Model MAXNAR is indicated for single patient use when continuous non-invasive arterial oxygen saturation and pulse rate monitoring is required for adult patients as indicated in the sensor directions for use. This device is for prescription use only.
Device Description
The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor, model MAXNAR is designed for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate in conjunction with a Nellcor Pulse Oximeter. The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor, model MAXNAR, is intended for prescription use with adult patients in hospitals, hospital-type facilities, and intra-hospital transport. The proposed device is not provided sterile
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K Number
K153258Device Name
Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars
Manufacturer
Surgical Instrument Service and Savings (dba Medline ReNewal
Date Cleared
2016-04-05
(147 days)
Product Code
NLM
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Surgical Instrument Service and Savings (dba Medline ReNewal
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocar is intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry. The trocar may be used with or without visualization for primary and secondary insertions.
Device Description
The Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocar 5-mm, 11-mm and 12-mm, with transparent cannula and obturator, allows optical entry for visualization of tissue layers during insertion. It is available in standard (100 mm), short (70 mm) and long (150 mm) cannula lengths. The obturator housing contains a scope retention mechanism and the trocar housing contains internal seals to prevent loss of pneumoperitoneum when instruments are inserted into a port or withdrawn completely from a port. The 5-mm, 11-mm and 12-mm Versaport seal system accommodate instruments indicated as 5-mm up to 11-mm and 12-mm respectively.
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K Number
K151405Device Name
Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue Technology
Manufacturer
Surgical Instrument Services and Savings(dba Medline ReNewal
Date Cleared
2016-01-26
(245 days)
Product Code
NLQ, NLO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Surgical Instrument Services and Savings(dba Medline ReNewal
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Medline ReNewal Reprocessed Harmonic ACE+ Shears without Adaptive Tissue Technology are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures.
Device Description
Medline ReNewal Reprocessed Harmonic ACE+ Shears without Adaptive Tissue Technology (originally manufactured by Ethicon Endo-Surgery) are cleaned, refurbished, tested, inspected, packaged, and sterilized for an additional clinical use.
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K Number
K143166Device Name
Medline ReNewal Reprocessed Compression Limb Sleeves
Manufacturer
Surgical Instrument Service and Savings (dba Medline ReNewal
Date Cleared
2015-01-16
(73 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
Surgical Instrument Service and Savings (dba Medline ReNewal
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Medline ReNewal Reprocessed Compression Limb Sleeves are designed to be used with a pump system to apply sequential compression to the lower limbs to prevent deep vein thrombosis.
Device Description
Medline ReNewal Reprocessed Compression Limb Sleeves are used with a pump system to apply sequential compression to the lower limbs (leg and foot). They are made of a variety of materials and come in various sizes. They are originally manufactured as single use devices.
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K Number
K142022Device Name
MEDLINE RENEWAL REPROCESSED GYRUS-DIEGO SINUS APPLICATION BLADES
Manufacturer
MEDLINE RENEWAL
Date Cleared
2014-12-19
(147 days)
Product Code
NLY
Regulation Number
874.4140Why did this record match?
Applicant Name (Manufacturer) :
MEDLINE RENEWAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Medline ReNewal Reprocessed Gyrus-Diego Sinus Application Blades are designed for use in limited sinus applications involving soft tissue and thin bone such as lamina papyracea.
Device Description
Medline ReNewal Reprocessed Gyrus-Diego Sinus Application Blades are sterile single use devices that have been cleaned, disinfected, inspected, refurbished, tested, packaged, labeled, and sterilized. The Medline ReNewal Reprocessed Gyrus-Diego Sinus Application Blades are originally manufactured by OLYMPUS/Gyrus ACMI.
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