| Primary Device ID | M685113210 |
| NIH Device Record Key | 54152a7b-3e46-4151-bd97-3f17526bf095 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 11321 |
| Catalog Number | 11321 |
| 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 |
| Phone | 941-755-7965 |
| CustomerService@ParcusMedical.com |
| Outer Diameter | 2.8 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M685113210 [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 | 2020-03-05 |
| Device Publish Date | 2020-02-26 |
| 00816342022491 - X-Twist Biocomposite | 2025-05-07 X-Twist Biocomposite Suture Anchor 4.75mm |
| 00816342025447 - X-Twist Biocomposite | 2025-05-07 X-Twist Biocomposite Suture Anchor 4.75mm |
| 00816342025454 - X-Twist Biocomposite | 2025-05-07 X-Twist Biocomposite Suture Anchor 4.75mm |
| 00816342025461 - X-Twist Biocomposite | 2025-05-07 X-Twist Biocomposite Suture Anchor 4.75mm |
| 00816342025478 - X-Twist Biocomposite | 2025-05-07 X-Twist Biocomposite Suture Anchor 5.5mm |
| 00816342025485 - X-Twist Biocomposite | 2025-05-07 X-Twist Biocomposite Suture Anchor 5.5mm |
| 00816342025492 - X-Twist Biocomposite | 2025-05-07 X-Twist Biocomposite Suture Anchor 5.5mm |
| 00816342025508 - X-Twist Biocomposite | 2025-05-07 X-Twist Biocomposite Suture Anchor 5.5mm |