| Primary Device ID | 08056646509942 |
| NIH Device Record Key | 583b083a-aa03-4ea0-afdb-418d2be477af |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tubing cover sleeve |
| Version Model Number | 12.U0022.00 |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 08056646509942 [Unit of Use] |
| GS1 | 08056646509959 [Primary] |
| NRU | Chair, Dental, Without Operative Unit |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-06 |
| Device Publish Date | 2023-06-28 |
| 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 |