| Primary Device ID | B1132L2HI185010 |
| NIH Device Record Key | be95ddc5-d93e-4a6c-8d86-b08634c1152a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Shoulder Innovations InSet 185 Impaction Stand Tower |
| Version Model Number | InSet 185 Impaction Stand Tower |
| Catalog Number | 2L2HI18501 |
| 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 | 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 | true |
| OTC Over-The-Counter | false |
| Phone | 616-294-1026 |
| info@shoulderinnovations.com | |
| Phone | 616-294-1026 |
| info@shoulderinnovations.com | |
| Phone | 616-294-1026 |
| info@shoulderinnovations.com | |
| Phone | 616-294-1026 |
| info@shoulderinnovations.com | |
| Phone | 616-294-1026 |
| info@shoulderinnovations.com | |
| Phone | 616-294-1026 |
| info@shoulderinnovations.com | |
| Phone | 616-294-1026 |
| info@shoulderinnovations.com | |
| Phone | 616-294-1026 |
| info@shoulderinnovations.com | |
| Phone | 616-294-1026 |
| info@shoulderinnovations.com | |
| Phone | 616-294-1026 |
| info@shoulderinnovations.com | |
| Phone | 616-294-1026 |
| info@shoulderinnovations.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B1132L2HI185010 [Primary] |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B1132L2HI185010]
Moist Heat or Steam Sterilization
[B1132L2HI185010]
Moist Heat or Steam Sterilization
[B1132L2HI185010]
Moist Heat or Steam Sterilization
[B1132L2HI185010]
Moist Heat or Steam Sterilization
[B1132L2HI185010]
Moist Heat or Steam Sterilization
[B1132L2HI185010]
Moist Heat or Steam Sterilization
[B1132L2HI185010]
Moist Heat or Steam Sterilization
[B1132L2HI185010]
Moist Heat or Steam Sterilization
[B1132L2HI185010]
Moist Heat or Steam Sterilization
[B1132L2HI185010]
Moist Heat or Steam Sterilization
[B1132L2HI185010]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-22 |
| Device Publish Date | 2025-12-12 |
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