| Primary Device ID | B1132N1KS000010 |
| NIH Device Record Key | 59476889-d129-4516-8622-b91fa307b342 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Shoulder Innovations TSA |
| Version Model Number | Surgical Utility Case |
| Catalog Number | 2N1KS00001 |
| Company DUNS | 080404519 |
| Company Name | Shoulder Innovations, Inc. |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 616-294-1026 |
| xxx@xx.xx | |
| Phone | 616-294-1026 |
| xxx@xx.xx | |
| Phone | 616-294-1026 |
| xxx@xx.xx | |
| Phone | 616-294-1026 |
| xxx@xx.xx | |
| Phone | 616-294-1026 |
| xxx@xx.xx | |
| Phone | 616-294-1026 |
| xxx@xx.xx | |
| Phone | 616-294-1026 |
| xxx@xx.xx | |
| Phone | 616-294-1026 |
| xxx@xx.xx |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B1132N1KS000010 [Primary] |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[B1132N1KS000010]
Ethylene Oxide
[B1132N1KS000010]
Ethylene Oxide
[B1132N1KS000010]
Ethylene Oxide
[B1132N1KS000010]
Ethylene Oxide
[B1132N1KS000010]
Ethylene Oxide
[B1132N1KS000010]
Ethylene Oxide
[B1132N1KS000010]
Ethylene Oxide
[B1132N1KS000010]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2021-08-10 |
| Device Publish Date | 2020-02-21 |
| B1132N1KS000010 | Steripack Surgical Utility Case |
| B1132N2AI200100 | Shoulder Innovations InSet Plus Glenoid Implant, Circular In Line Peg, 20mm x 10°, UHMWPE |
| B1132N2AI200050 | Shoulder Innovations InSet Plus Glenoid Implant, Circular In Line Peg, 20mm x 5°, UHMWPE |
| B1130S0CI200080 | Shoulder Innovations - TSA. Glenoid Circular In Line Peg. 20m x 8mm. UHMWPE. |
| B1130S0CI200060 | Shoulder Innovations - TSA. Glenoid Circular In Line Peg. 20m x 6mm. UHMWPE. |
| B1132N1KS000150 | Steripack Surgical Utility Case Generic |
| B1132N2AI330100 | Shoulder Innovations InSet Plus Glenoid Implant, Circular In Line Peg, 33mm x 10°, UHMWPE |
| B1132N2AI330050 | Shoulder Innovations InSet Plus Glenoid Implant, Circular In Line Peg, 33mm x 5°, UHMWPE |
| B1132N1AI330100 | Shoulder Innovations InSet Plus Glenoid Trial, Circular In Line Peg, 33mm x 10°, Stainless Stee |
| B1132N1AI330050 | Shoulder Innovations InSet Plus Glenoid Trial, Circular In Line Peg, 33mm x 5°, Stainless Steel |
| B1132N1AC330100 | Shoulder Innovations InSet Plus Glenoid Trial, Circular Center Peg, 33mm x 10°, Stainless Steel |
| B1132N1AC330050 | Shoulder Innovations InSet Plus Glenoid Trial, Circular Center Peg, 33mm x 5°, Stainless Steel |
| B1130S0CI330080 | Shoulder Innovations - TSA. Glenoid Circular In Line Peg. 33 mm x 8 mm. UHMWPE. |
| B1130S0CI330060 | Shoulder Innovations - TSA. Glenoid Circular In Line Peg. 33mm x 6mm. UHMWPE. |