Specialty Lower Extremity Drape ORI-SDL-LEAD

GUDID 00854150007408

ORI Specialty Lower Extremity Drape

Operating Room Innovations, Inc.

Patient surgical drape, single-use

• Primary Device ID: 00854150007408
• NIH Device Record Key: d580cd12-f50f-4a24-ba4f-2bd42d457994
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Specialty Lower Extremity Drape
• Version Model Number: ORI-SDL-LEAD
• Catalog Number: ORI-SDL-LEAD
• Company DUNS: 080246656
• Company Name: Operating Room Innovations, Inc.
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854150007262 [Previous]
GS1	00854150007408 [Primary]
GS1	10854150007405 [Unit of Use]

FDA Product Code

• PUI: Drape, Surgical, Exempt

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-09
• Device Publish Date: 2026-01-01

Devices Manufactured by Operating Room Innovations, Inc.

• 00854150007392 - Specialty Anterior Hip Drape: 2026-01-09 ORI Specialty Anterior Hip Drape
• 00854150007408 - Specialty Lower Extremity Drape: 2026-01-09ORI Specialty Lower Extremity Drape
• 00854150007408 - Specialty Lower Extremity Drape: 2026-01-09 ORI Specialty Lower Extremity Drape
• 00854150007422 - Universal Upper Extremity Drape: 2026-01-09 ORI Universal Upper Extremity Drape
• 26975424191642 - Operating Room Innovations, Inc: 2023-04-13 Shield Guards-Removable Peel Away, 2 per Pouch
• 16975085709401 - ORI: 2023-04-12 HaloFit Large with Face Shield AAMI IV
• 16975085709418 - ORI: 2023-04-12 HaloFit XXX-Large with Face Shield AAMI IV
• 26975424191451 - ORI: 2023-04-12 Face Shield, Attached with Full Head Covering
• 26975424191468 - ORI: 2023-04-12 ORI Drop Stop