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Na Sm-4011M

by Omega Surgical Instruments, Inc. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00817438027673 UDI-DIDate29 Apr 2022ListedStatusListed GUDID: 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  • Withdrawn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

Generic Name
Surgical saw blade, oscillating, single-use
Model / Reference
SM-4011M
Primary DI / UDI-DI
00817438027673
FDA Product Code
GFA
GMDN Term
Surgical saw blade, oscillating, single-use
Device Class
Class I
Regulation Number
878.4820
GUDID distribution status
In Commercial Distribution
Sterilization Method
Radiation Sterilization

Related devices

Category: Surgical saw blade, oscillating, single-use

Other devices from Omega Surgical Instruments, Inc.

See all devices from Omega Surgical Instruments, Inc. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

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