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Topfine Insulin Syringe 29Gx8mm 1.0ml

by Medexel Co., Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08809445833646 UDI-DI Date23 Apr 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Topfine Insulin Syringe
Generic Name
Insulin syringe/needle, basic
Model / Reference
29Gx8mm 1.0ml
Primary DI / UDI-DI
08809445833646
510(k) Number
FDA Product Code
FMF
GMDN Term
Insulin syringe/needle, basic
Device Class
Class II
Regulation Number
880.5860
GUDID distribution status
In Commercial Distribution
Size
Needle Gauge — 29 Gauge
Length — 8 Millimeter

Related devices

Cleared under the same submission (K063348)

Show all (12)

Other devices from Medexel Co., Ltd.

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No