Sizer 8MM

GUDID M209171850

BIOPRO, INC.

Bone awl
Primary Device IDM209171850
NIH Device Record Keyb25e385e-4835-4756-a5c9-899bf11afef2
Commercial Distribution StatusIn Commercial Distribution
Brand NameSizer 8MM
Version Model Number17185
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
HIBCCM209171850 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWTTemplate

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M209171850]

Moist Heat or Steam Sterilization

[M209171850]

Moist Heat or Steam Sterilization

[M209171850]

Moist Heat or Steam Sterilization

[M209171850]

Moist Heat or Steam Sterilization

[M209171850]

Moist Heat or Steam Sterilization

[M209171850]

Moist Heat or Steam Sterilization

[M209171850]

Moist Heat or Steam Sterilization

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
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