| 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 |
| 07630542722035 - Surgical Manual Instrument | 2026-02-18 Internal separator for panier 179mm |
| 07630345734525 - Mpact 3D Metal | 2026-02-10 Mpact 3D metal Shell Multi Hole Thin Ø44mm |
| 07630345752857 - Mpact 3D Metal | 2026-02-10 Mpact 3D metal Shell Two Hole Ø44mm |
| 07630542743931 - Mpact 3D Metal | 2026-02-10 Mpact 3D metal Shell Two-Hole Ø42 T |
| 07630542743948 - Mpact 3D Metal | 2026-02-10 Mpact 3D metal Shell Two-Hole Ø44 T |
| 07630542743955 - Mpact 3D Metal | 2026-02-10 Mpact 3D metal Shell Two-Hole Ø46 T |
| 07630542743962 - Mpact 3D Metal | 2026-02-10 Mpact 3D metal Shell Two-Hole Ø48 T |
| 07630542743979 - Mpact 3D Metal | 2026-02-10 Mpact 3D metal Shell Two-Hole Ø50 T |