| Primary Device ID | M209171880 |
| NIH Device Record Key | 2c310fc7-371f-47fb-8428-5d5ca4cf5179 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sizer 11MM |
| Version Model Number | 17188 |
| 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M209171880 [Primary] |
| HWT | Template |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M209171880]
Moist Heat or Steam Sterilization
[M209171880]
Moist Heat or Steam Sterilization
[M209171880]
Moist Heat or Steam Sterilization
[M209171880]
Moist Heat or Steam Sterilization
[M209171880]
Moist Heat or Steam Sterilization
[M209171880]
Moist Heat or Steam Sterilization
[M209171880]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-05-14 |
| Device Publish Date | 2019-05-06 |
| 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 |