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StabiliT ER2 Bone Cement and Saturate Mixing System 1688

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 Number00850696006424 UDI-DI Date17 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  • Withdrawn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

Specification

GUDID

Trade Name
StabiliT ER2 Bone Cement and Saturate Mixing System
Generic Name
Orthopaedic cement, non-antimicrobial
Model / Ref / Catalog
1688
Primary DI / UDI-DI
00850696006424
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