FDA.reportPublic FDA data

PEAK MEDICAL

Primary DI
G4533324129VT0
Brand
PEAK MEDICAL
Company
Peak Medical Distribution Inc.
Model
33241-29VT
Device description
AV Fistula Tunneler 4mm vein tip w/luer adaptor
Published
2025-03-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DWSInstruments, Surgical, Cardiovascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G4533324129VT0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Vein stripper, reusableA hand-held surgical instrument designed to manually excise (strip by stab avulsion) a length or section of a vein from a patient, typically varicose veins [superficial dilated tortuous veins especially of the legs (greater saphenous veins)]. It is typically designed as: 1) a flexible stainless steel cable with a stripping cup or disk (commonly known as an olive) attached to one end, and a handle at the other (some types can employ a guide tip); or 2) a rigid or semi-rigid rod terminating in a closed ring or loop (also known as a ring stripper). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
078393632
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G4533352797GM8M50PEAK MEDICAL3352-797GM8M52026-05-27
G453332414200PEAK MEDICAL3324-14-202026-05-08
G45313110753150PEAK MEDICAL131-1075-3152026-05-06
G453332321055BC010PEAK MEDICAL33-23-21055BC-012026-05-06
G453BH72800PEAK MEDICALBH7-2802026-03-30
G453230117BCL0PEAK MEDICAL23-0117BC-L2026-03-23
G453230117BCR0PEAK MEDICAL23-0117BC-R2026-03-23
G453CFK1000PEAK MEDICALCFK-1002026-03-23
G453333481030PEAK MEDICAL3324-81032024-04-11
G453FA06160PEAK MEDICALFA0-6162026-03-19
G453AR130PEAK MEDICALAR-132026-03-11
G453PM11812CH1PEAK MEDICALPM11-812-CH2026-03-10
G453PM11815CH0PEAK MEDICALPM11-815-CH2026-03-10
G4532420530BC0PEAK MEDICAL24205-30-BC2026-02-24
G453335200112L0PEAK MEDICAL3352001-12L2026-01-05
G4533352003290PEAK MEDICAL3352003-292026-01-05
G4533353003310PEAK MEDICAL3353003-312026-01-05
G453333553810PEAK MEDICAL3335-53812026-01-02
G453CD351170PEAK MEDICALCD3-51172025-12-07
G453CD433180PEAK MEDICALCD4-33182025-12-07

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Primary DI, Brand, Company table
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00846159039849SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039856SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039863SCANLAN® ForcepsSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039870SCANLAN® InstrumentSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039887SCANLAN® InstrumentSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039894SCANLAN® InstrumentSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039900SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039917SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039924SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-27
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08022057015860TIE Intracorporeal Knot Placement Assist and COLLAR Papillary Muscle ExposureCORCYM SRLDWS2026-02-03
08022057015877JOSEPH LAMELAS Knot PusherCORCYM SRLDWS2026-02-03
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