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Sterile Angled Triangle Blade for Endotrac Endoscopic Carpal Tunnel Release 2054-A

by Restore Surgical LLC

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10815375022123 UDI-DI Date23 Sep 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  • Withdrawn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
Sterile Angled Triangle Blade for Endotrac Endoscopic Carpal Tunnel Release
Generic Name
Manual scalpel blade, single-use
Model / Reference
2054-A
Primary DI / UDI-DI
10815375022123
FDA Product Code
HRX
GMDN Term
Manual scalpel blade, single-use
Device Class
Class II
Regulation Number
888.1100
GUDID distribution status
Not in Commercial Distribution

Other devices from Restore Surgical LLC

Properties

  • Sterile
  • Single Use
  • Contains Latex
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

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