| Primary Device ID | M685108030 |
| NIH Device Record Key | 12cbf2c4-bab6-4eb2-a42d-7762bc26a4be |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 10803 |
| 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 | |
| Phone | 941-755-7965 |
| CustomerService@ParcusMedical.com | |
| Phone | 941-755-7965 |
| CustomerService@ParcusMedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M685108030 [Primary] |
| MAI | Fastener, Fixation, Biodegradable, 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 | 2020-05-25 |
| Device Publish Date | 2020-05-15 |
| 00816342023573 - Parcus Instrumentation | 2023-08-07 10mm SLiK Fix Drill Bit |
| 00816342023580 - Parcus Instrumentation | 2023-08-07 1.8mm Reusable Draw Tight Drill Bit with Stop |
| 00816342023634 - Parcus Instrumentation | 2023-08-07 3.0mm x 100mm Reusable Drill Bit with Stop |
| 00816342023658 - Parcus Instrumentation | 2023-08-07 28 Knotless Reusable Drill Bit |
| 00816342023726 - Parcus Instrumentation | 2023-08-07 1.1mm x 400mm Nitinol Guide Wire |
| 00816342023740 - Parcus Instrumentation | 2023-08-07 28 Knotless Reusable Drill Guide, Hip Length |
| 00816342023795 - Knotless Push-In Suture Anchor | 2023-08-07 35 Knotless Push-In Suture Anchor with Driver |
| 00816342023931 - Twist PEEK Suture Anchor | 2023-08-07 4.5mm Twist, screw-in, suture anchor, w/2 1.6mm suture tapes (wht/blu & wht/blk) |