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Universal Upper Extremity Drape ORI-SDL-UPXD

by Operating Room Innovations, 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 Number00854150007422 UDI-DI Date1 Jan 2026ListedStatusListed 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  • Withdrawn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
Universal Upper Extremity Drape
Generic Name
Patient surgical drape, single-use
Model / Ref / Catalog
ORI-SDL-UPXD
Primary DI / UDI-DI
00854150007422
FDA Product Code
PUI
GMDN Term
Patient surgical drape, single-use
Device Class
Class II
Regulation Number
878.4370
GUDID distribution status
In Commercial Distribution

Other devices from Operating Room Innovations, Inc.

Properties

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

Other properties (9)

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