| Primary Device ID | 00813892020540 |
| NIH Device Record Key | 8a96e15e-8537-4533-9f53-4d81e30bfd50 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Titanium-TSY™ Shoulder Plate |
| Version Model Number | TCS-017 |
| Catalog Number | TCS-017 |
| Company DUNS | 068109169 |
| Company Name | Orthopedic Sciences Inc |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 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 |
| Phone | +1(562)799-5550 |
| info@orthopedicsciences.com | |
| Phone | +1(562)799-5550 |
| info@orthopedicsciences.com | |
| Phone | +1(562)799-5550 |
| info@orthopedicsciences.com |
| Length | 17 Millimeter |
| Length | 17 Millimeter |
| Length | 17 Millimeter |
| Special Storage Condition, Specify | Between 0 and 0 *Keep at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Keep at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Keep at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Keep at room temperature |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep at room temperature |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813892020540 [Primary] |
| HRS | PLATE, FIXATION, BONE |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-11-16 |
| 00813892020762 | 140° Titanium-TSY™ Shoulder Plate |
| 00813892020755 | 135° Titanium-TSY™ Shoulder Plate |
| 00813892020748 | 130° Titanium-TSY™ Shoulder Plate |
| 00813892020731 | 125° Titanium-TSY™ Shoulder Plate |
| 00813892020724 | 35mm Titanium Compression Screw |
| 00813892020717 | 30mm Titanium Compression Screw |
| 00813892020700 | 25mm Titanium Compression Screw |
| 00813892020694 | 22.5mm Titanium Compression Screw |
| 00813892020687 | 20mm Titanium Compression Screw |
| 00813892020540 | 17.5mm Titanium Compression Screw |
| 00813892020533 | 15mm Titanium Compression Screw |