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Oscar Pro 1

by Orthofix, Inc. 35 variants

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number18053800895061 UDI-DI Date10 Jun 2021ListedStatusListed GUDID: 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  • Withdrawn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
Oscar Pro
Generic Name
Instrument tray, reusable
Model / Ref / Catalog
1, O4TRAY-02
Description
OSCAR PRO LID TRAY
Primary DI / UDI-DI
18053800895061
FDA Product Code
JDX
GMDN Term
Instrument tray, reusable
Device Class
Class II
Regulation Number
888.4580
GUDID distribution status
In Commercial Distribution

Other devices from Orthofix, Inc.

See all devices from Orthofix, Inc. →

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (10)

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