Omnisleeve

GUDID 08056646508785

Sheaths 240x7 cm with inserter Omnisleeve

OMNIA SRL

Medical equipment drape, single-use

• Primary Device ID: 08056646508785
• NIH Device Record Key: 9348e5e5-7c60-40b7-b4d8-b05db34f9f04
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omnisleeve
• Version Model Number: 22.U0007.00
• Company DUNS: 447696675
• Company Name: OMNIA SRL
• Device Count: 10
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08056646508785 [Unit of Use]
GS1	08056646508792 [Primary]

FDA Product Code

• FWZ: Operating Room Accessories Table Tray

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: 2023-07-06
• Device Publish Date: 2023-06-28

On-Brand Devices [Omnisleeve]

• 08056646502561: sterile and disposable protective barriers in water-repellent TNT, PVC, latex and polyurethane f
• 08056646508785: Sheaths 240x7 cm with inserter Omnisleeve
• 08056646508761: Sheaths 120x7 cm with inserter Omnisleeve