Clover Staple # Leg Complete Kit

GUDID M209196780

BIOPRO, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device IDM209196780
NIH Device Record Key1791019c-57e7-41fd-890b-a06e1e4043a4
Commercial Distribution StatusIn Commercial Distribution
Brand NameClover Staple # Leg Complete Kit
Version Model Number19678
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
HIBCCM209196780 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M209196780]

Moist Heat or Steam Sterilization


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.

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