Ori Uh-3

by Operating Room Innovations, Inc.

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

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00854150007231 UDI-DI	Date7 Jan 2019Listed	StatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Ori
Generic Name: Face splash shield, single-use
Model / Ref / Catalog: UH-3

Primary DI / UDI-DI: 00854150007231
FDA Product Code: KPY
GMDN Term: Face splash shield, single-use

Device Class: Class I
Regulation Number: 892.6500
GUDID distribution status: Not in Commercial Distribution

Other devices from Operating Room Innovations, Inc.

Specialty Anterior Hip Drape ORI-SDL-DAHIP

Class II
Specialty Lower Extremity Drape ORI-SDL-LEAD

Class II
Universal Upper Extremity Drape ORI-SDL-UPXD

Class II
Modular Toga

Class II

Properties

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

Other properties (8)

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