| Primary Device ID | 00816342025331 |
| NIH Device Record Key | b38ffcc3-de15-42bc-bb8f-c546689bf4fe |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | X-Twist PEEK |
| Version Model Number | XT24702 |
| Catalog Number | XT24702 |
| 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 | 9417557965 |
| ParcusCS@Anika.com | |
| Phone | 9417557965 |
| ParcusCS@Anika.com | |
| Phone | 9417557965 |
| ParcusCS@Anika.com | |
| Phone | 9417557965 |
| ParcusCS@Anika.com | |
| Phone | 9417557965 |
| ParcusCS@Anika.com | |
| Phone | 9417557965 |
| ParcusCS@Anika.com | |
| Phone | 9417557965 |
| ParcusCS@Anika.com | |
| Phone | 9417557965 |
| ParcusCS@Anika.com | |
| Phone | 9417557965 |
| ParcusCS@Anika.com |
| Outer Diameter | 4.75 Millimeter |
| Outer Diameter | 4.75 Millimeter |
| Outer Diameter | 4.75 Millimeter |
| Outer Diameter | 4.75 Millimeter |
| Outer Diameter | 4.75 Millimeter |
| Outer Diameter | 4.75 Millimeter |
| Outer Diameter | 4.75 Millimeter |
| Outer Diameter | 4.75 Millimeter |
| Outer Diameter | 4.75 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816342025331 [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 | 2022-07-21 |
| Device Publish Date | 2022-07-13 |
| 00816342025386 | X-Twist PEEK 6.25mm suture anchor, 1 x No 2 suture |
| 00816342025379 | X-Twist PEEK 5.5mm suture anchor, 2 x 1.6mm tapes, black |
| 00816342025362 | X-Twist PEEK 5.5mm suture anchor, 2 x 1.6mm tapes, blue |
| 00816342025355 | X-Twist PEEK 5.5mm suture anchor, 1 x No 2 suture |
| 00816342025348 | X-Twist PEEK 4.75mm suture anchor, 2 x 1.6mm tapes, black |
| 00816342025331 | X-Twist PEEK 4.75mm suture anchor, 2 x 1.6mm tapes, blue |
| 00816342025324 | X-Twist PEEK 5.5mm suture anchor, 2 x 1.6mm tapes |
| 00816342025317 | X-Twist PEEK 4.75mm suture anchor, 1 x No 2 suture |
| 00816342025300 | X-Twist PEEK suture anchor, 1 x 1.6mm tape |