FLEXIBLE REAMER WITH Multiple Flute TIP, 14 MM

GUDID M209216990

BIOPRO, INC.

Bone-resection orthopaedic reamer, reusable
Primary Device IDM209216990
NIH Device Record Keya02c31d5-aaaa-4785-8535-9b271a6393b2
Commercial Distribution StatusIn Commercial Distribution
Brand NameFLEXIBLE REAMER WITH Multiple Flute TIP, 14 MM
Version Model Number21699
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
HIBCCM209216990 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HTOReamer

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-09
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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