| Primary Device ID | 00816342024037 |
| NIH Device Record Key | 440f6772-12e4-408d-afde-43d55200a6a9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Twist Knotless |
| Version Model Number | 11259 |
| Company DUNS | 859961950 |
| Company Name | PARCUS MEDICAL LLC |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| 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 |
|---|---|
| GS1 | 00816342024037 [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 | 2023-08-07 |
| Device Publish Date | 2023-07-29 |
| M685111670 | 6.25 x 15 Twist Knotless PEEK Suture Anchor |
| M685111660 | 5.5 x 15 Twist Knotless PEEK Suture Anchor |
| M685111650 | 4.75 x 15 Twist Knotless PEEK Suture Anchor |
| 00816342024013 | 5.5 x 15 Twist Knotless PEEK Suture Anchor |
| 00816342024051 | 6.25 x 15mm, Twist, knotless, DEX, screw-in, suture anchor, w/suture threader, PEEK |
| 00816342024044 | 5.5 x 15mm, Twist, knotless, DEX, screw-in, suture anchor, w/suture threader, PEEK |
| 00816342024037 | 4.75 x 15mm, Twist, knotless, DEX, screw-in, suture anchor, w/suture threader, PEEK |
| 00816342024020 | 6.25 x 15mm, Twist, knotless, screw-in, suture anchor, w/suture threader, PEEK |
| 00816342024006 | 4.75 x 15mm, Twist, knotless, screw-in, suture anchor, w/suture threader, PEEK |