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Pen Needles Classic 01-3204

by Sandstone Medical (Suzhou) Inc.

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number16972857299337 UDI-DI Date11 Oct 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Pen Needles Classic
Generic Name
Autoinjector needle
Model / Reference
01-3204
Primary DI / UDI-DI
16972857299337
FDA Product Code
FMI
GMDN Term
Autoinjector needle
Device Class
Class II
Regulation Number
880.5570
GUDID distribution status
In Commercial Distribution

Other devices from Sandstone Medical (Suzhou) Inc.

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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