Primary Device ID | M209176490 |
NIH Device Record Key | 19114be9-5a04-451b-8666-d7df047a27e1 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Drill Guide 11 - 13MM |
Version Model Number | 17649 |
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 | M209176490 [Primary] |
FZX | Guide, Surgical, Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[M209176490]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2020-04-06 |
Device Publish Date | 2019-05-01 |
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 |