ORI ORI-SDL-LEAD

GUDID 00854150007279

ORI-Specialty Drape Line-Lower Extremity Adaptable Drape

OPERATING ROOM INNOVATIONS, INC.

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• Primary Device ID: 00854150007279
• NIH Device Record Key: abfcf92c-c8a3-47e9-8555-e26f52f31903
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORI
• Version Model Number: ORI-SDL-LEAD
• Catalog Number: ORI-SDL-LEAD
• Company DUNS: 080246656
• Company Name: OPERATING ROOM INNOVATIONS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854150007262 [Primary]
GS1	00854150007279 [Package]; Contains: 00854150007262; Package: Case [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101598

FDA Product Code

• KKX: Drape, Surgical

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: 2020-07-08
• Device Publish Date: 2020-06-30

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