DRILL BIT SQC 1.5MM 85/18MM

GUDID 00810012485739

BIOPRO, INC.

Orthopaedic prosthesis implantation instrument, reusable
Primary Device ID00810012485739
NIH Device Record Keyeb4e7863-f535-4799-a7bc-a3092c38da00
Commercial Distribution StatusIn Commercial Distribution
Brand NameDRILL BIT SQC 1.5MM 85/18MM
Version Model Number18960
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
GS100810012485739 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-20
Device Publish Date2019-06-12

Devices Manufactured by BIOPRO, INC.

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