| Primary Device ID | 00816342025003 |
| NIH Device Record Key | 78e823bd-6f16-446c-8a3a-139b926e0adc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Synd EZ |
| Version Model Number | 11225 |
| Company DUNS | 859961950 |
| Company Name | PARCUS MEDICAL LLC |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 | 00816342025003 [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 | 2023-07-30 |
| 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) |