| Primary Device ID | 00811596030179 |
| NIH Device Record Key | de520d8e-92b2-4a65-8e4e-a4fc47224567 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CSR Shoulder System |
| Version Model Number | 1227-4126 |
| Company DUNS | 079702565 |
| Company Name | CATALYST ORTHOSCIENCE 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 | 800-587-5137 |
| ddavison@catalystortho.com | |
| Phone | 800-587-5137 |
| ddavison@catalystortho.com | |
| Phone | 800-587-5137 |
| ddavison@catalystortho.com | |
| Phone | 800-587-5137 |
| ddavison@catalystortho.com | |
| Phone | 800-587-5137 |
| ddavison@catalystortho.com | |
| Phone | 800-587-5137 |
| ddavison@catalystortho.com | |
| Phone | 800-587-5137 |
| ddavison@catalystortho.com | |
| Phone | 800-587-5137 |
| ddavison@catalystortho.com | |
| Phone | 800-587-5137 |
| ddavison@catalystortho.com | |
| Phone | 800-587-5137 |
| ddavison@catalystortho.com | |
| Phone | 800-587-5137 |
| ddavison@catalystortho.com | |
| Phone | 800-587-5137 |
| ddavison@catalystortho.com | |
| Phone | 800-587-5137 |
| ddavison@catalystortho.com | |
| Phone | 800-587-5137 |
| ddavison@catalystortho.com | |
| Phone | 800-587-5137 |
| ddavison@catalystortho.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00811596030179 [Primary] |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00811596030179]
Moist Heat or Steam Sterilization
[00811596030179]
Moist Heat or Steam Sterilization
[00811596030179]
Moist Heat or Steam Sterilization
[00811596030179]
Moist Heat or Steam Sterilization
[00811596030179]
Moist Heat or Steam Sterilization
[00811596030179]
Moist Heat or Steam Sterilization
[00811596030179]
Moist Heat or Steam Sterilization
[00811596030179]
Moist Heat or Steam Sterilization
[00811596030179]
Moist Heat or Steam Sterilization
[00811596030179]
Moist Heat or Steam Sterilization
[00811596030179]
Moist Heat or Steam Sterilization
[00811596030179]
Moist Heat or Steam Sterilization
[00811596030179]
Moist Heat or Steam Sterilization
[00811596030179]
Moist Heat or Steam Sterilization
[00811596030179]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-01-15 |
| Device Publish Date | 2020-01-07 |
| 00811596030087 | Press-Fit Humeral Size I |
| 00811596030070 | Press-Fit Humeral Size H |
| 00811596030063 | Press-Fit Humeral Implant Size G |
| 00811596030056 | Press-Fit Humeral Implant Size E |
| 00811596030049 | Press-Fit Humeral Size F |
| 00811596030032 | Press-Fit Humeral Implant Size D |
| 00811596030025 | Press-Fit Humeral Implant Size C |
| 00811596030018 | Press Fit Humeral Implant Size A |
| 00811596030001 | Press-Fit Humeral Implant Size B |
| 00811596030162 | 3-Peg Augment Trial - 10°, Size: Large |
| 00811596030155 | 3-Peg Augment Trial - 10°, Size: Medium |
| 00811596030148 | 3-Peg Augment Trial - 10°, Size: Small |
| 00811596030131 | Augmented 3-Peg Glenoid Implant - 10°, Size: Large |
| 00811596030124 | Augmented 3-Peg Glenoid Implant - 10°, Size: Medium |
| 00811596030117 | Augmented 3-Peg Glenoid Implant - 10°, Size: Small |
| 00811596030353 | XS Humeral Modular Cut Guide 1 |
| 00811596030346 | XXS Angled Reamer |
| 00811596030339 | XS Angled Reamer |
| 00811596030193 | Small Humeral Cover |
| 00811596030179 | 5.75mm Drill Guide Locking Pin |
| 00851388006975 | Sterile Humeral Cut Guide Fixation Kit |
| 00811596031404 | Monolithic Cut Guide I |