| Primary Device ID | 07630971212947 |
| NIH Device Record Key | e116fcd4-6f08-49dc-be71-7f44d6a1b610 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sports Med Instruments |
| Version Model Number | 05.05.10.0078 |
| Company DUNS | 488227125 |
| Company Name | Medacta International SA |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07630971212947 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07630971212947]
Moist Heat or Steam Sterilization
[07630971212947]
Moist Heat or Steam Sterilization
[07630971212947]
Moist Heat or Steam Sterilization
[07630971212947]
Moist Heat or Steam Sterilization
[07630971212947]
Moist Heat or Steam Sterilization
[07630971212947]
Moist Heat or Steam Sterilization
[07630971212947]
Moist Heat or Steam Sterilization
[07630971212947]
Moist Heat or Steam Sterilization
[07630971212947]
Moist Heat or Steam Sterilization
[07630971212947]
Moist Heat or Steam Sterilization
[07630971212947]
Moist Heat or Steam Sterilization
[07630971212947]
Moist Heat or Steam Sterilization
[07630971212947]
Moist Heat or Steam Sterilization
[07630971212947]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-12-17 |
| Device Publish Date | 2020-12-09 |
| 07630971232020 | Sports Med. – Single Bundle ACL tray – 2 levels |
| 07630971213029 | Femoral Aimer AM Ø9-10 |
| 07630971213012 | Femoral Aimer AM Ø7-8 |
| 07630971213005 | Knee Microfracture 60° |
| 07630971212992 | Table Measuring System |
| 07630971212985 | Bone Wedge Chisel |
| 07630971212961 | Screwdriver T40 Cannulated |
| 07630971212947 | Screwdriver T25 Cannulated |
| 07630971212923 | Screwdriver T20 Cannulated |
| 07630971212909 | Tibial aimer bullet Ø6 |
| 07630971212893 | Tibial Aimer Adjustable Angle |
| 07630971212886 | Oval Dilator Ø12 |
| 07630971212879 | Oval Dilator Ø11.5 |
| 07630971212862 | Oval Dilator Ø11 |
| 07630971212855 | Oval Dilator Ø10.5 |
| 07630971212848 | Oval Dilator Ø10 |
| 07630971212831 | Oval Dilator Ø9.5 |
| 07630971212824 | Oval Dilator Ø9 |
| 07630971212817 | Oval Dilator Ø8.5 |
| 07630971212800 | Oval Dilator Ø8 |
| 07630971212794 | Oval Dilator Ø7.5 |
| 07630971212787 | Oval Dilator Ø7 |
| 07630971212770 | Oval Dilator Ø6.5 |
| 07630971212763 | Oval Dilator Ø6 |
| 07630971212756 | Screwdriver handle - Quick connection |
| 07630971212725 | Graft Measuring Device - LARGE |
| 07630971212718 | Graft Measuring Device - SMALL |
| 07630040724494 | Nitinol GuideWire Ø1.1 L385 |
| 07630040723961 | Suture retriever |
| 07630040723954 | Soft Tissue Penetrator (NH001.74) - Right |
| 07630040723947 | Soft Tissue Penetrator (NH000.74) - Left |
| 07630040723930 | Soft Tissue Penetrator (NH002.80)-Straight |
| 07630040723893 | Loose Body Grasper Forceps L.S.(GR045.80)-Straight |
| 07630040723886 | Alligator Grasper Forceps (GR032.80)-Straight |
| 07630040723855 | Oval Punch (ST020.76) - Upbiter |
| 07630971232259 | SH Arthro - General Tray |
| 07630971218970 | HIP arthro - Access tray (single level) |
| 07630971218963 | HIP arthro - General tray (double level) |
| 07630040728621 | Acorn Reamer Ø4.5 L195 |
| 07630040728478 | Acorn Reamer Ø5 L195 |
| 07630040724487 | SH Arthro - V-Pipe Handle |
| 07630040724470 | SH Arthro - V-Pipe reduced |
| 07630040724463 | SH Arthro - V-Pipe rounded |
| 07630040724456 | SH Arthro - Knot pusher |
| 07630040724449 | SH Arthro - Rasp |
| 07630040724432 | SH Arthro - Elevator |
| 07630040724425 | SH Arthro - Probe |
| 07630040724418 | HIP Arthro - Knot Pusher 180 |
| 07630040724401 | HIP Arthro - Knot Pusher 150 |
| 07630040724395 | HIP Arthro - Switching stick handle |