| Primary Device ID | M209176300 |
| NIH Device Record Key | 089e951d-56c4-441e-9160-8bdc2d2853e8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SMALL STAPLE 11x8 |
| Version Model Number | 17630 |
| Company DUNS | 618749857 |
| Company Name | BIOPRO, 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 | true |
| 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 |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M209176300 [Primary] |
| JDR | Staple, Fixation, Bone |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-11-23 |
| Device Publish Date | 2015-09-16 |
| M209177990 - THUMB MOD HEAD TITANIUM 13MM+2 | 2024-07-08 |
| M209178000 - THUMB MOD HEAD TITANIIUM 12MM | 2024-07-08 |
| M209178010 - THUMB MOD HEAD TITANIUM 12MM+2 | 2024-07-08 |
| M209178060 - THUMB MOD HEAD TITANIUM 14MM | 2024-07-08 |
| M209178070 - THUMB MOD HEAD TITANIUM 14MM+2 | 2024-07-08 |
| M209178080 - THUMB MOD HEAD TITANIUM 15MM | 2024-07-08 |
| M209178090 - THUMB MOD HEAD TITANIUM 15MM+2 | 2024-07-08 |
| M209177980 - THUMB MOD HEAD TITANIUM 13MM | 2024-06-07 |