| Primary Device ID | 10801741074322 |
| NIH Device Record Key | 001bd08f-2b10-419c-af2c-2a0d2eca2ea8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OptiFix Absorbable Fixation System |
| Version Model Number | 0113127 |
| Catalog Number | 0113127 |
| 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 | |
| Phone | +1(800)562-0027 |
| medical.services@crbard.com |
| Length | 39 Centimeter |
| Length | 39 Centimeter |
| Length | 39 Centimeter |
| Length | 39 Centimeter |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00801741074325 [Primary] |
| GS1 | 10801741074322 [Package] Contains: 00801741074325 Package: CA [5 Units] In Commercial Distribution |
| GDW | STAPLE, IMPLANTABLE |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-01-08 |
| Device Publish Date | 2015-04-16 |
| 10801741074322 | OptiFix Absorbable Fixation System 39 cm x 5mm Cannula, 15 Absorbable Fasteners |
| 10801741074315 | OptiFix Absorbable Fixation System 39cm x 5mm Cannula, 30 Absorbable Fasteners |