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Found 17 results
510(k) Data Aggregation
K Number
K041332Device Name
JOEY CLAMP OPENING TOOL
Manufacturer
MATERNUS, INC.
Date Cleared
2004-06-25
(37 days)
Product Code
HFW
Regulation Number
884.4530Why did this record match?
Product Code :
HFW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The indications for use of the Joey Clamp Opening Tool is to open the Joey Clamp® umbilical cord clamp.
Device Description
Not Found
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K Number
K033846Device Name
KAEN YIH UMBILICAL CORD CLAMP
Manufacturer
KAEN YIH ENTERPRISE CO., LTD.
Date Cleared
2004-03-11
(91 days)
Product Code
HFW
Regulation Number
884.4530Why did this record match?
Product Code :
HFW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Umbilical Cord Clamp is indicated for use following a live birth. It provides a means of constricting the umbilical cord in order to prevent loss of blood as the cord dries and shrinks after birth. It is used immediately following delivery of the infant and prior to the separation of umbilical cord between mother and infant.
Device Description
Not Found
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K Number
K020718Device Name
SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILE
Manufacturer
PRECISION DYNAMICS CORP.
Date Cleared
2002-06-03
(90 days)
Product Code
HFW
Regulation Number
884.4530Why did this record match?
Product Code :
HFW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Securline Umbilical Cord Clamp is used to clamp over the umbilical cord of a newborn at delivery. The device is used to hold the cord securely and prevent blood loss and seepage as the curd dries and shrinks after the birth.
Device Description
The Securline® Umbilical Cord Clamp is a single use, disposable, molded plastic device, unit packaged, (sterile) or bulk packaged (nonsterile).
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K Number
K021055Device Name
BUSSE UMBILICAL CORD CLAMP CUTTER
Manufacturer
BUSSE HOSPITAL DISPOSABLES, INC.
Date Cleared
2002-04-29
(28 days)
Product Code
HFW
Regulation Number
884.4530Why did this record match?
Product Code :
HFW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use is to cut the umbilical cord clamp off a newborn's umbilical cord.
Device Description
The subject device is a cutter designed to safely cut the umbilical cord clamp. The device is composed I fier book acrise is a outadiene Styrene) Doc 26720NT Natural resin with a stainless steel blade. The device does not make contact with the patient. The device is provided non-sterile and is labeled for single natient use. The subject device is packaged in a 3"x5" Glassine Bag and will be included in the dispenser box with the Busse Posi-Grip Umbilical Cord Clamps.
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K Number
K012917Device Name
DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B
Manufacturer
DYNAREX CORP.
Date Cleared
2001-11-28
(90 days)
Product Code
HFW
Regulation Number
884.4530Why did this record match?
Product Code :
HFW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Dynarex Umbilical Cord Clamp is a device used to compress the umbilical cord. Federal (USA) law restricts this device to sale by or on the order of a physician.
Device Description
The Dynarex Umbilical Cord Clamp instrument is substantially equivalent in function and intended use to these examples of products presently on the market. Specifically, the Dynarex Umbilical Cord Clamp is exactly similar in functional design, performs the same functions and has the same intended use as these presently distributed devices. The packaging methods and packaging materials are exactly the same, respectively.
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K Number
K011621Device Name
KOALA CLAMP, KOALA CLAMP AND CUTTER
Manufacturer
MATERNUS, INC.
Date Cleared
2001-08-10
(77 days)
Product Code
HFW
Regulation Number
884.4530Why did this record match?
Product Code :
HFW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The indications for use of the Koala Clamp & Cutter are to simultaneously clamp and cut the umbilical cord.
Device Description
Not Found
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K Number
K010695Device Name
KOALA CLAMP
Manufacturer
MATERNUS, INC.
Date Cleared
2001-05-03
(56 days)
Product Code
HFW
Regulation Number
884.4530Why did this record match?
Product Code :
HFW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K010835Device Name
POSI-GRIP UMBILICAL CORD CLAMP, STERILE, MODEL 384, POSI-GRIP UMBILICAL CORD CLAMP, NON-STERILE, MODEL 385
Manufacturer
BUSSE HOSPITAL DISPOSABLES, INC.
Date Cleared
2001-04-30
(41 days)
Product Code
HFW
Regulation Number
884.4530Why did this record match?
Product Code :
HFW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000227Device Name
UMBICUT
Manufacturer
POLLAK (INTL.), LTD.
Date Cleared
2000-04-27
(94 days)
Product Code
HFW
Regulation Number
884.4530Why did this record match?
Product Code :
HFW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K994367Device Name
UMBILICAL CORD CLAMP
Manufacturer
MEDICAL SALES CO.
Date Cleared
2000-03-17
(81 days)
Product Code
HFW
Regulation Number
884.4530Why did this record match?
Product Code :
HFW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sterile, single-use, disposable umbilical cord clamp, used to clamp over the umbilical cord of a newborn at delivery. The device is used to hold the cord securely and prevent blood loss and seepage as the cord dries and shrinks after the birth, prior to and after cutting.
Device Description
Umbilical cord clamp, injection-molded plastic, blue, singleuse, disposable, packaged, sterile (sterilized by 100% EtO gas).
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