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N/A Ds-87104

by Omega Surgical Instruments, Inc.

Listed FDA GUDID listing, no authorization on record

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 Number00817438020704 UDI-DI Date17 Jun 2022ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Surgical saw blade, oscillating, single-use
Model / Reference
DS-87104
Primary DI / UDI-DI
00817438020704
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
  • Manufacturing Date

Other properties (7)

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