Cannulated Drill Sterile 3.0-3.5MM

GUDID M209192350

BIOPRO, INC.

Cannulated surgical drill bit, single-use, sterile
Primary Device IDM209192350
NIH Device Record Key8e32ed47-81c0-43b3-b78f-6d12466141c5
Commercial Distribution StatusIn Commercial Distribution
Brand NameCannulated Drill Sterile 3.0-3.5MM
Version Model Number19235
Company DUNS618749857
Company NameBIOPRO, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM209192350 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HTWBit, Drill

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-14
Device Publish Date2019-05-06

Devices Manufactured by BIOPRO, INC.

M209177990 - THUMB MOD HEAD TITANIUM 13MM+22024-07-08
M209178000 - THUMB MOD HEAD TITANIIUM 12MM2024-07-08
M209178010 - THUMB MOD HEAD TITANIUM 12MM+22024-07-08
M209178060 - THUMB MOD HEAD TITANIUM 14MM2024-07-08
M209178070 - THUMB MOD HEAD TITANIUM 14MM+22024-07-08
M209178080 - THUMB MOD HEAD TITANIUM 15MM2024-07-08
M209178090 - THUMB MOD HEAD TITANIUM 15MM+22024-07-08
M209177980 - THUMB MOD HEAD TITANIUM 13MM2024-06-07

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.