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Sterile Micro Hook Blade, EDIN I 4058

by Restore Surgical LLC GUDID

Listed FDA GUDID listing, not in commercial distribution

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10815375022215 UDI-DIDate23 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  • Withdrawn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

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
Sterile Micro Hook Blade, EDIN I
Generic Name
Manual scalpel blade, single-use
Model / Reference
4058
Primary DI / UDI-DI
10815375022215
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
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Implantable: No
  • 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