| Primary Device ID | 07630971248274 |
| NIH Device Record Key | c74273c4-fe62-464c-8c0b-44b403fd90fa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Shoulder Instruments |
| Version Model Number | 04.01.10.0361 |
| 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 | 07630971248274 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07630971248274]
Moist Heat or Steam Sterilization
[07630971248274]
Moist Heat or Steam Sterilization
[07630971248274]
Moist Heat or Steam Sterilization
[07630971248274]
Moist Heat or Steam Sterilization
[07630971248274]
Moist Heat or Steam Sterilization
[07630971248274]
Moist Heat or Steam Sterilization
[07630971248274]
Moist Heat or Steam Sterilization
[07630971248274]
Moist Heat or Steam Sterilization
[07630971248274]
Moist Heat or Steam Sterilization
[07630971248274]
Moist Heat or Steam Sterilization
[07630971248274]
Moist Heat or Steam Sterilization
[07630971248274]
Moist Heat or Steam Sterilization
[07630971248274]
Moist Heat or Steam Sterilization
[07630971248274]
Moist Heat or Steam Sterilization
[07630971248274]
Moist Heat or Steam Sterilization
[07630971248274]
Moist Heat or Steam Sterilization
[07630971248274]
Moist Heat or Steam Sterilization
[07630971248274]
Moist Heat or Steam Sterilization
[07630971248274]
Moist Heat or Steam Sterilization
[07630971248274]
Moist Heat or Steam Sterilization
[07630971248274]
Moist Heat or Steam Sterilization
[07630971248274]
Moist Heat or Steam Sterilization
[07630971248274]
Moist Heat or Steam Sterilization
[07630971248274]
Moist Heat or Steam Sterilization
[07630971248274]
Moist Heat or Steam Sterilization
[07630971248274]
Moist Heat or Steam Sterilization
[07630971248274]
Moist Heat or Steam Sterilization
[07630971248274]
Moist Heat or Steam Sterilization
[07630971248274]
Moist Heat or Steam Sterilization
[07630971248274]
Moist Heat or Steam Sterilization
[07630971248274]
Moist Heat or Steam Sterilization
[07630971248274]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-12-31 |
| Device Publish Date | 2020-12-23 |
| 07630971278004 | Shoulder System - Humeral long inst. tray - trials Acorn Reamer Ø6.5 L195 |
| 07630971277991 | Shoulder System - Humeral long inst. tray Acorn Reamer Ø6.5 L195 |
| 07630971249028 | Intramedullary reamer for long stem ZH - Ø14 Acorn Reamer Ø6.5 L195 |
| 07630971249011 | Trial humeral long diaphysis - L160 - 9 Acorn Reamer Ø6.5 L195 |
| 07630971249004 | Intramedullary reamer for long stem ZH - Ø10 Acorn Reamer Ø6.5 L195 |
| 07630971248984 | Trial anatomic metaphysis 135° - 12 Acorn Reamer Ø6.5 L195 |
| 07630971248960 | Trial anatomic metaphysis 135° - 14 Acorn Reamer Ø6.5 L195 |
| 07630971248953 | Trial humeral long diaphysis - L200 - 9 Acorn Reamer Ø6.5 L195 |
| 07630971248946 | Trial humeral long diaphysis - L200 - 6 Acorn Reamer Ø6.5 L195 |
| 07630971248922 | Backtable long stem adapter - 11 Acorn Reamer Ø6.5 L195 |
| 07630971248915 | Intramedullary reamer for long stem ZH - Ø12 Acorn Reamer Ø6.5 L195 |
| 07630971248908 | Backtable long stem adapter - 13 Acorn Reamer Ø6.5 L195 |
| 07630971248892 | Trial humeral long diaphysis - L200 - 7 Acorn Reamer Ø6.5 L195 |
| 07630971248854 | Trial humeral long diaphysis - L200 - 10 Acorn Reamer Ø6.5 L195 |
| 07630971248847 | Intramedullary reamer for long stem ZH - Ø15 Acorn Reamer Ø6.5 L195 |
| 07630971248823 | Backtable long stem adapter - 8 Acorn Reamer Ø6.5 L195 |
| 07630971248809 | Backtable long stem adapter - 15 Acorn Reamer Ø6.5 L195 |
| 07630971248793 | Trial humeral long diaphysis - L200 - 12 Acorn Reamer Ø6.5 L195 |
| 07630971248779 | Trial humeral long diaphysis - L160 - 14 Acorn Reamer Ø6.5 L195 |
| 07630971248762 | Trial anatomic metaphysis 135° - 9 Acorn Reamer Ø6.5 L195 |
| 07630971248748 | Intramedullary reamer for long stem ZH - Ø16 Acorn Reamer Ø6.5 L195 |
| 07630971248731 | Trial humeral long diaphysis - L200 - 11 Acorn Reamer Ø6.5 L195 |
| 07630971248724 | Backtable long stem adapter - 14 Acorn Reamer Ø6.5 L195 |
| 07630971248717 | Trial humeral long diaphysis - L200 - 16 Acorn Reamer Ø6.5 L195 |
| 07630971248694 | Trial humeral long diaphysis - L160 - 15 Acorn Reamer Ø6.5 L195 |
| 07630971248663 | Intramedullary reamer for long stem ZH - Ø9 Acorn Reamer Ø6.5 L195 |
| 07630971248656 | Backtable long stem adapter - 9 Acorn Reamer Ø6.5 L195 |
| 07630971248649 | Backtable assembly block for long stem Acorn Reamer Ø6.5 L195 |
| 07630971248632 | Trial humeral long diaphysis - L200 - 15 Acorn Reamer Ø6.5 L195 |
| 07630971248601 | Intramedullary reamer for long stem ZH - Ø8 Acorn Reamer Ø6.5 L195 |
| 07630971248564 | Intramedullary reamer for long stem ZH - Ø11 Acorn Reamer Ø6.5 L195 |
| 07630971248557 | Trial anatomic metaphysis 135° - 8 Acorn Reamer Ø6.5 L195 |
| 07630971248526 | Trial anatomic metaphysis 135° - 16 Acorn Reamer Ø6.5 L195 |
| 07630971248519 | Trial humeral long diaphysis - L160 - 11 Acorn Reamer Ø6.5 L195 |
| 07630971248502 | Backtable long stem adapter - 7 Acorn Reamer Ø6.5 L195 |
| 07630971248489 | Trial anatomic metaphysis 135° - 15 Acorn Reamer Ø6.5 L195 |
| 07630971248465 | Trial humeral long diaphysis - L160 - 8 Acorn Reamer Ø6.5 L195 |
| 07630971248427 | Trial anatomic metaphysis 135° - 11 Acorn Reamer Ø6.5 L195 |
| 07630971248403 | Backtable long stem adapter - 10 Acorn Reamer Ø6.5 L195 |
| 07630971248397 | Trial anatomic metaphysis 135° - 7 Acorn Reamer Ø6.5 L195 |
| 07630971248373 | Trial humeral long diaphysis - L160 - 12 Acorn Reamer Ø6.5 L195 |
| 07630971248359 | Intramedullary reamer for long stem ZH - Ø6 Acorn Reamer Ø6.5 L195 |
| 07630971248311 | Trial humeral long diaphysis - L200 - 14 Acorn Reamer Ø6.5 L195 |
| 07630971248304 | Trial humeral long diaphysis - L160 - 13 Acorn Reamer Ø6.5 L195 |
| 07630971248281 | Intramedullary reamer for long stem ZH - Ø7 Acorn Reamer Ø6.5 L195 |
| 07630971248274 | Trial anatomic metaphysis 135° - 6 Acorn Reamer Ø6.5 L195 |
| 07630971248243 | Trial anatomic metaphysis 135° - 13 Acorn Reamer Ø6.5 L195 |
| 07630971248229 | Trial humeral long diaphysis - L160 - 6 Acorn Reamer Ø6.5 L195 |
| 07630971248199 | Backtable long stem adapter - 16 Acorn Reamer Ø6.5 L195 |
| 07630971248182 | Trial humeral long diaphysis - L200 - 13 Acorn Reamer Ø6.5 L195 |