STAPLE POSITIONER 10X8

GUDID 00810012484121

BIOPRO, INC.

Orthopaedic prosthesis implantation instrument, single-use
Primary Device ID00810012484121
NIH Device Record Keyfc870d95-4e7d-47a1-bba4-71d8dcc5f893
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTAPLE POSITIONER 10X8
Version Model Number19512
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
GS100810012484121 [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

On-Brand Devices [STAPLE POSITIONER 10X8]

M20919512019512
0081001248412119512

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