Drill Bit Blue 2.0mm 115mm AO

GUDID M209226800

BIOPRO, INC.

Surgical drill guide, single-use
Primary Device IDM209226800
NIH Device Record Keya15b84fa-c9d9-40e0-8eac-0d31ad4de1ab
Commercial Distribution StatusIn Commercial Distribution
Brand NameDrill Bit Blue 2.0mm 115mm AO
Version Model Number226780
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
HIBCCM209226800 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HTWBit, Drill

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M209226800]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-25
Device Publish Date2019-12-17

Devices Manufactured by BIOPRO, INC.

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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

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