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Ori Ori-Sdl-Lead

by Operating Room Innovations, Inc. 2 variants

Listed FDA GUDID listing, not in commercial distribution

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

Overview

A specialty drape designed to cover a portion of a patient’s anatomy during surgical procedures, providing a barrier to cross-contamination. This single-use device is available in various designs and is not designed with specific heat-reflective or laser resistant materials.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06975085708612 UDI-DI Date3 Apr 2023ListedStatusListed GUDID: not 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  • Withdrawn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
Ori
Generic Name
Patient surgical drape, single-use
Model / Ref / Catalog
ORI-SDL-LEAD
Primary DI / UDI-DI
06975085708612
FDA Product Code
KKX
GMDN Term
Patient surgical drape, single-use
Device Class
Class II
Regulation Number
878.4370
GUDID distribution status
Not in Commercial Distribution

Other devices from Operating Room Innovations, Inc.

Properties

  • Sterile
  • Single Use
  • Over-the-Counter
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No