FIRST MPJ HEMI COMPLETE KIT

GUDID 00810012485708

BIOPRO, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID00810012485708
NIH Device Record Keyefbbc074-7860-4606-ad17-ded338c1b57f
Commercial Distribution StatusIn Commercial Distribution
Brand NameFIRST MPJ HEMI COMPLETE KIT
Version Model Number17368
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
GS100810012485708 [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 Date2019-06-14
Device Publish Date2019-06-06

Devices Manufactured by BIOPRO, INC.

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M209178080 - THUMB MOD HEAD TITANIUM 15MM2024-07-08
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M209177980 - THUMB MOD HEAD TITANIUM 13MM2024-06-07

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