| Primary Device ID | 10801741136556 |
| NIH Device Record Key | 7b881889-8149-4bb8-853d-909e4ba56255 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OptiFix AT Absorbable Fixation System with Articulating Technology |
| Version Model Number | 0113315 |
| Catalog Number | 0113315 |
| Company DUNS | 001191048 |
| Company Name | Davol Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 |
| Phone | +1(800)562-0027 |
| medical.services@crbard.com |
| Length | 37 Centimeter |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00801741136559 [Primary] |
| GS1 | 10801741136556 [Package] Contains: 00801741136559 Package: CA [5 Units] In Commercial Distribution |
| GDW | Staple, implantable |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-07-26 |
| Device Publish Date | 2019-07-18 |
| 10801741136563 | OptiFix AT Absorbable Fixation System with Articulating Technology - 30 absorbable fasteners |
| 10801741136556 | OptiFix AT Absorbable Fixation System with Articulating Technology – 15 absorbable fasteners |