Transparent bag 67x75 cm with sliding ties for physiodispensers or for control u

GUDID 08052141310014

Transparent bag 67x75 cm with sliding ties for physiodispensers or for control units

OMNIA SRL

Medical equipment drape, single-use

• Primary Device ID: 08052141310014
• NIH Device Record Key: 2bd96f08-45e8-4a7e-8cbb-34aca67509f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Transparent bag 67x75 cm with sliding ties for physiodispensers or for control u
• Version Model Number: 12.A3012.00
• Company DUNS: 447696675
• Company Name: OMNIA SRL
• Device Count: 12
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08052141310014 [Unit of Use]
GS1	08052141310021 [Primary]

FDA Product Code

• LYU: Accessory, Surgical Apparel

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

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