| Primary Device ID | B390AR406845L1 |
| NIH Device Record Key | aff9992c-4285-4d5b-95d8-9035b7ab8891 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Reprocessed SutureLasso, 45 Deg, Curve Left |
| Version Model Number | AR-4068-45L |
| 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 | B390AR406845L1 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-23 |
| Device Publish Date | 2024-12-13 |
| B3902141071 - Reprocessed Distal Rib Clear Cannula with Obturator, 5.5mm x 75mm | 2024-12-23 |
| B3902141081 - Reprocessed Threaded Clear Cannula with Obturator, 5.5mm x 75mm | 2024-12-23 |
| B390AR406845L1 - Reprocessed SutureLasso, 45 Deg, Curve Left | 2024-12-23 |
| B390AR406845L1 - Reprocessed SutureLasso, 45 Deg, Curve Left | 2024-12-23 |
| B390S8966561 - Reprocessed Sagittal Saw Blade, 90 x 19 x 1.27mm | 2024-12-23 |
| B390AR8750131 - Reprocessed 3.7mm Cannulated Drill Bit | 2024-11-27 |
| B390722901351 - Reprocessed Werewolf Irrigation Tube Set | 2024-11-18 |
| B390AR65301 - Reprocessed Twist-in Cannula w/Obturator, 8.25mm x 7cm | 2024-10-28 |
| B39057S000221 - Reprocessed Mica Drill Bit, 2.2mm | 2024-10-24 |