| Primary Device ID | 07630542771224 |
| NIH Device Record Key | d2b26862-b0c5-4430-80f1-0b39f9e6031c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Shoulder Instrument |
| Version Model Number | 04.01.10.1006 |
| 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 | true |
| 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 | 07630542771224 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07630542771224]
Moist Heat or Steam Sterilization
[07630542771224]
Moist Heat or Steam Sterilization
[07630542771224]
Moist Heat or Steam Sterilization
[07630542771224]
Moist Heat or Steam Sterilization
[07630542771224]
Moist Heat or Steam Sterilization
[07630542771224]
Moist Heat or Steam Sterilization
[07630542771224]
Moist Heat or Steam Sterilization
[07630542771224]
Moist Heat or Steam Sterilization
[07630542771224]
Moist Heat or Steam Sterilization
[07630542771224]
Moist Heat or Steam Sterilization
[07630542771224]
Moist Heat or Steam Sterilization
[07630542771224]
Moist Heat or Steam Sterilization
[07630542771224]
Moist Heat or Steam Sterilization
[07630542771224]
Moist Heat or Steam Sterilization
[07630542771224]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-31 |
| Device Publish Date | 2025-03-21 |
| 07630542771224 | Beluga Retractor - Right |
| 07630542771217 | Beluga Retractor - Left |
| 07630542771200 | Anterior Glenoid Retractor |
| 07630542771194 | Crego Retractor - Large |
| 07630542771187 | Crego Retractor - Small |