PUSHER 4 LEG 14X12

GUDID 00810012483971

BIOPRO, INC.

Orthopaedic prosthesis implantation instrument, single-use
Primary Device ID00810012483971
NIH Device Record Keyee530de7-ff46-41ec-a53c-5283e4773158
Commercial Distribution StatusIn Commercial Distribution
Brand NamePUSHER 4 LEG 14X12
Version Model Number18300
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
GS100810012483971 [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 [PUSHER 4 LEG 14X12]

M20918300018300
0081001248397118300

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.