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Feel Ject(FIS-024, U-100, 0.5cc, 32G x 8mm)

by Feel Tech Bio Co., Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

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 Number08800045102040 UDI-DI Date6 Feb 2026ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-1504-2009 FDA Unclassified (pre-2012) initiated 9 Apr 2009

    Needles separate from the barrel of the syringes.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Insulin syringe/needle, basic
Model / Reference
FIS-024
Primary DI / UDI-DI
08800045102040
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

Related devices

Cleared under the same submission (K070917)

Show all (12)

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Properties

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

Other properties (9)

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