DRILL SCREW SLEEVE

GUDID M209213880

BIOPRO, INC.

Surgical drill guide, reusable
Primary Device IDM209213880
NIH Device Record Key1ee4fed4-758f-4d47-91cd-926ece037969
Commercial Distribution StatusIn Commercial Distribution
Brand NameDRILL SCREW SLEEVE
Version Model Number21388
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 Usefalse
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
HIBCCM209213880 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FZXGuide, Surgical, Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M209213880]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-04-06
Device Publish Date2019-05-01

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

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