Omnitex C

GUDID 08056646506712

Conical sheath Omnitex C - white - nitrile

OMNIA SRL

Medical equipment drape, single-use

• Primary Device ID: 08056646506712
• NIH Device Record Key: c5567262-0050-4bac-9a64-07f20aa33a08
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omnitex C
• Version Model Number: 30.Z0131.00
• Company DUNS: 447696675
• Company Name: OMNIA SRL
• Device Count: 500
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08056646506705 [Primary]
GS1	08056646506712 [Unit of Use]

FDA Product Code

• NRU: Chair, Dental, Without Operative Unit

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-28
• Device Publish Date: 2023-06-20

Devices Manufactured by OMNIA SRL

• 08056646500017 - Sterile PTFE Surgical Suture: 2025-04-22 PTFE Suture 75 cm - 3/0 - 19 mm 3/8 Needle - Body Reverse Cutting
• 08056646500031 - Sterile PTFE Surgical Suture: 2025-04-22 PTFE Suture 75 cm - 4/0 - 16 mm 3/8 Needle - Body Reverse Cutting
• 08056646500055 - Sterile PTFE Surgical Suture: 2025-04-22 PTFE Suture 75 cm - 5/0 - 12 mm 1/2 Needle - Body Reverse Cutting
• 08056646500079 - Sterile PTFE Surgical Suture: 2025-04-22 PTFE Suture 75 cm - 6/0 - 11 mm 1/2 Needle - Body Reverse Cutting
• 08056646500086 - Sterile PTFE Surgical Suture: 2025-04-22 PTFE Suture 75 cm - 5/0 -12 mm Needle 3/8 - Body Reverse Cutting
• 08056646500116 - Sterile PTFE Surgical Suture: 2025-04-22 PTFE Suture 75 cm - 6/0 - Diamond tip 10 mm Needle 1/2 - Round Body
• 08056646500123 - Sterile PTFE Surgical Suture: 2025-04-22 PTFE Suture 75 cm - 4/0 - Diamond tip 18 mm Needle 3/8 - Round Body
• 08056646500154 - Sterile PTFE Surgical Suture: 2025-04-22 PTFE Suture 75 cm - 5/0 - Diamond tip 18 mm Needle 3/8 - Round Body