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StabiliT Bone Cement and Saturate Mixing System 4457

by Dfine, Inc. GUDID

Listed FDA GUDID listing, not in commercial distribution

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850696006028 UDI-DIDate17 Dec 2015ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

GUDID

Trade Name
StabiliT Bone Cement and Saturate Mixing System
Generic Name
Orthopaedic cement, non-antimicrobial
Model / Ref / Catalog
4457
Primary DI / UDI-DI
00850696006028
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
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

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