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EMERGE MEDICAL & Design 208.443.EM

by Emerge Medical

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 Number00886020013165 UDI-DI Date8 Jul 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  • Withdrawn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
EMERGE MEDICAL & Design
Generic Name
Orthopaedic bone screw, non-bioabsorbable, non-sterile
Model / Ref / Catalog
208.443.EM
Primary DI / UDI-DI
00886020013165
FDA Product Code
HWC
GMDN Term
Orthopaedic bone screw, non-bioabsorbable, non-sterile
Device Class
Class II
Regulation Number
888.3040
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Other devices from Emerge Medical

See all devices from Emerge Medical →

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number

Other properties (11)

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