Primary Device ID | 07630040729406 |
NIH Device Record Key | 53d1fe54-6a1c-49b3-bb04-7bc7a6783fdf |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SportMed Instruments |
Version Model Number | 05.05.10.0021 |
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 | 07630040729406 [Primary] |
LXH | Orthopedic Manual Surgical Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[07630040729406]
Moist Heat or Steam Sterilization
[07630040729406]
Moist Heat or Steam Sterilization
[07630040729406]
Moist Heat or Steam Sterilization
[07630040729406]
Moist Heat or Steam Sterilization
[07630040729406]
Moist Heat or Steam Sterilization
[07630040729406]
Moist Heat or Steam Sterilization
[07630040729406]
Moist Heat or Steam Sterilization
[07630040729406]
Moist Heat or Steam Sterilization
[07630040729406]
Moist Heat or Steam Sterilization
[07630040729406]
Moist Heat or Steam Sterilization
[07630040729406]
Moist Heat or Steam Sterilization
[07630040729406]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-12-10 |
Device Publish Date | 2020-12-02 |
07630040729468 | Knee Probe |
07630040729451 | Hammer |
07630040729444 | PSP Impactor |
07630040729437 | Tendon Stripper Open |
07630040729420 | Tendon Stripper Close |
07630040729413 | Reverse length gauge |
07630040729406 | Standard length gauge |
07630040729390 | Tibial Aimer Bullet MEDIUM |
07630040729383 | Tibial Aimer Bullet SMALL |
07630040729376 | Tibial Aimer Arc LEFT |
07630040729369 | Tibial Aimer Arc RIGHT |
07630040729352 | Femoral Aimer 50 |
07630040729345 | Femoral Aimer 35 |
07630040729338 | Suture support |
07630040729321 | Tibial button support |
07630040729314 | Femoral button support |
07630040729307 | Prep Plastic board |
07630040729291 | Graft clamp |
07630040729284 | PrepTable |
07630040729277 | Graft Measuring Device |
07630040729260 | Femoral Dilator LARGE |
07630040729253 | Femoral Dilator MEDIUM |
07630040729246 | Femoral Dilator SMALL |
07630040729239 | Tibial Dilator LARGE |
07630040729222 | Tibial Dilator MEDIUM |
07630040729215 | Tibial Dilator SMALL |
07630040729208 | Slide Hammer |
07630040717045 | Bone Drill Ø4.5 L260 |
07630040717038 | Bone Drill Ø4.5 L230 |
07630040717021 | Acorn Reamer Ø 4.5 |
07630040717014 | Special K-wire |
07630040717007 | Passing wire Ø2.4 L380 |
07630040716994 | K-wire Ø2.4 L220 |
07630040716987 | K-wire Ø2.4 L380 |
07630971255692 | FastShuttle - Disposable Needle – STERILE (5x) |
07630971232082 | MectaFlip 150mm |
07630971232075 | MectaFlip 120mm |
07630971232068 | MectaFlip 80mm |
07630040731676 | Horizontal Cutter - MARS ACL MEDIUM |
07630040731652 | Horizontal Cutter - 15x6 |
07630040731645 | Horizontal Cutter - 15x5 |
07630040731638 | Horizontal Cutter - 15x3 |
07630040731621 | Horizontal Cutter - 10x4 |
07630040731584 | Vertical Cutter - 14x7 |
07630040731577 | Vertical Cutter - 14x5 |
07630040731560 | Vertical Cutter - 12x7 |
07630040731553 | Vertical Cutter - 12x5 |
07630040731546 | Vertical Cutter - 10x7 |
07630040731539 | Vertical Cutter - 10x5 |
07630040731522 | Vertical Cutter - 9x7 |