| Primary Device ID | 00816342020374 |
| NIH Device Record Key | 8259b3d3-8fc6-42e2-9b80-053199b31d31 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 10042 |
| Catalog Number | 10042 |
| Company DUNS | 859961950 |
| Company Name | PARCUS MEDICAL LLC |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| 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 |
| ParcusCS@Anika.com | |
| Phone | 941-755-7965 |
| ParcusCS@Anika.com | |
| Phone | 941-755-7965 |
| ParcusCS@Anika.com | |
| Phone | 941-755-7965 |
| ParcusCS@Anika.com | |
| Phone | 941-755-7965 |
| ParcusCS@Anika.com | |
| Phone | 941-755-7965 |
| ParcusCS@Anika.com | |
| Phone | 941-755-7965 |
| ParcusCS@Anika.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816342020374 [Primary] |
| HXX | Screwdriver |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00816342020374]
Moist Heat or Steam Sterilization
[00816342020374]
Moist Heat or Steam Sterilization
[00816342020374]
Moist Heat or Steam Sterilization
[00816342020374]
Moist Heat or Steam Sterilization
[00816342020374]
Moist Heat or Steam Sterilization
[00816342020374]
Moist Heat or Steam Sterilization
[00816342020374]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-08-16 |
| Device Publish Date | 2021-08-06 |
| 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 |