| Primary Device ID | 08800039100465 |
| NIH Device Record Key | c6e4edad-fbfc-47da-9a69-f0bc89e3a568 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fixone All Suture Anchor |
| Version Model Number | FAS-1652803jw |
| Company DUNS | 963422810 |
| Company Name | AJU PHARM. CO., LTD. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 08800039100465 [Primary] |
| MBI | Fastener, Fixation, Nondegradable, 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 | 2025-01-14 |
| Device Publish Date | 2025-01-06 |
| 08800039100847 | Fixone All suture anchor consists of one “fix Suture” and one,two or three non-absorbable Su |
| 08800039100502 | Fixone All suture anchor consists of one “fix Suture” and one,two or three non-absorbable Su |
| 08800039100465 | Fixone All suture anchor consists of one “fix Suture” and one,two or three non-absorbable Su |