Primary Device ID | 07630542730153 |
NIH Device Record Key | bdbda13c-d665-4e52-b293-cff5164befa7 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | MyShoulder Planner |
Version Model Number | 5.3SSWPL |
Company DUNS | 488227125 |
Company Name | Medacta International SA |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
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 | true |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07630542730153 [Primary] |
KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-02-14 |
Device Publish Date | 2025-02-06 |
07630040749466 - Hip Instrument | 2025-03-31 Inclination rod |
07630040749473 - Hip Instrument | 2025-03-31 Anteversion rod |
07630040754026 - Hip Instrument | 2025-03-31 Mpact Posterior alignment cup impactor |
07630345794994 - Knee Instruments | 2025-03-31 Femoral Conversion Set Sz 1 - L |
07630345795007 - Knee Instruments | 2025-03-31 Femoral Conversion Set Sz 1 - R |
07630345795014 - Knee Instruments | 2025-03-31 Femoral Conversion Set Sz 2 - L |
07630345795021 - Knee Instruments | 2025-03-31 Femoral Conversion Set Sz 2 - R |
07630345795038 - Knee Instruments | 2025-03-31 Femoral Conversion Set Sz 3 - L |