| Primary Device ID | B390AR10001 |
| NIH Device Record Key | 3d89a17f-16ae-42da-99d1-97f223815cc7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Reprocessed Suture Passer, Transosseous |
| Version Model Number | AR-1000 |
| Company DUNS | 785616934 |
| Company Name | SURETEK MEDICAL |
| Device Count | 1 |
| 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 |
|---|---|
| HIBCC | B390AR10001 [Primary] |
| MDM | Instrument, Manual, Surgical, General Use |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-27 |
| Device Publish Date | 2024-05-17 |
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| B390AR10001 - Reprocessed Suture Passer, Transosseous | 2024-05-27 |
| B390AR10001 - Reprocessed Suture Passer, Transosseous | 2024-05-27 |