| Primary Device ID | 03760304680632 |
| NIH Device Record Key | fd3f8e4e-d7e8-4725-8301-6bc45f438b53 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ecoFIX Needle |
| Version Model Number | ecoFIX® Needle Ø 5.5 mm Threaded Double-Loaded Sut |
| Catalog Number | EPAV355CLA |
| Company DUNS | 772462123 |
| Company Name | S.B.M |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| Manufacturing Date | true |
| 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 |
| Outer Diameter | 5.5 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Storage Environment Temperature | Between 0 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 33 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03760304680632 [Primary] |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-19 |
| Device Publish Date | 2023-09-11 |
| 03760304680649 | Ø 6.5 mm anchor mounted on reel with 2 round needled sutures |
| 03760304680632 | Ø 5.5 mm anchor mounted on reel with 2 round needled sutures |
| 03760304680625 | Ø 4.5 mm anchor mounted on reel with 2 round needled sutures |