DRILL GUIDE SINGLE HOLE

GUDID 00810012483858

BIOPRO, INC.

Surgical drill guide, single-use
Primary Device ID00810012483858
NIH Device Record Keya4bcb151-058a-4b07-80b3-551bb7065ac4
Commercial Distribution StatusIn Commercial Distribution
Brand NameDRILL GUIDE SINGLE HOLE
Version Model Number17656
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810012483858 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FZXGuide, Surgical, Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-08-09
Device Publish Date2019-06-10

On-Brand Devices [DRILL GUIDE SINGLE HOLE]

M2091756017656
0081001248422019467
0081001248385817656

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