| Primary Device ID | B1132R1R2700250 |
| NIH Device Record Key | cf158750-89a2-447c-84fa-7a99a71d37f5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Shoulder Innovations Inset Reverse Total Shoulder |
| Version Model Number | RSA Glenoid Baseplate 27mm x 0 x 25mm |
| Catalog Number | 2R1R270025 |
| 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 |
| 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 | B1132R1R2700250 [Primary] |
| PHX | Shoulder Prosthesis, Reverse Configuration |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[B1132R1R2700250]
Radiation Sterilization
[B1132R1R2700250]
Radiation Sterilization
[B1132R1R2700250]
Radiation Sterilization
[B1132R1R2700250]
Radiation Sterilization
[B1132R1R2700250]
Radiation Sterilization
[B1132R1R2700250]
Radiation Sterilization
[B1132R1R2700250]
Radiation Sterilization
[B1132R1R2700250]
Radiation Sterilization
[B1132R1R2700250]
Radiation Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-09-03 |
| Device Publish Date | 2021-08-26 |
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