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PTFE Peelable Introducer Kit 7142

by Greatbatch Ltd

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 9 Nov 2026. What this means

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00802526486128 UDI-DI Date27 Sep 2018ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
PTFE Peelable Introducer Kit
Generic name
Vascular catheter introduction set, nonimplantable
Model / reference
7142
Primary DI / UDI-DI
00802526486128
FDA product code
DYB
GMDN term
Vascular catheter introduction set, nonimplantable
Device class
Class II
Regulation number
870.1340
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 0.89 Millimeter
Length — 60 Centimeter
Needle Gauge — 18 Gauge
Total Volume — 12 Milliliter
Lumen/Inner Diameter — 2.6 Millimeter
Length — 25 Centimeter

Related devices

Category: Vascular catheter introduction set, nonimplantable

Other devices from Greatbatch Ltd

See all devices from Greatbatch Ltd →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date

Other properties (8)

  • Sterilise before use: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No