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StabiliT First Fracture Kit 3353-01

by Dfine, Inc.

Listed FDA GUDID listing, not in commercial distribution

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850696006233 UDI-DIDate27 Jan 2016ListedStatusListed GUDID: not 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  • Withdrawn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
StabiliT First Fracture Kit
Generic Name
Orthopaedic cement, non-antimicrobial
Model / Ref / Catalog
3353-01
Primary DI / UDI-DI
00850696006233
FDA Product Code
NDN
GMDN Term
Orthopaedic cement, non-antimicrobial
Device Class
Class II
Regulation Number
888.3027
GUDID distribution status
Not in Commercial Distribution

Other devices from Dfine, Inc.

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (7)

  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No