OMNISLEEVE

GUDID 08056646502561

sterile and disposable protective barriers in water-repellent TNT, PVC, latex and polyurethane for the treatment center, the quiver, the lamp handles, the control panels, the switches, the handpieces, the suction tubes, the end part of the X-rays , cameras, trays and instrument holders, contaminated waste containers, basins and swabs for disinfection.

OMNIA SRL

Medical equipment drape, single-use

• Primary Device ID: 08056646502561
• NIH Device Record Key: 0e6da818-2419-4817-9c28-449e571a1d0a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OMNISLEEVE
• Version Model Number: 22.U0001.00
• Company DUNS: 447696675
• Company Name: OMNIA SRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• 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	08056646502561 [Primary]
GS1	08056646502578 [Package]; Package: [100 Units]; In Commercial Distribution

FDA Product Code

• NRD: Unit, Operative Dental, Accessories

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: 2020-07-01
• Device Publish Date: 2020-06-23

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