WRIST STAPLE INSTRUMENT TRAY

GUDID 00810012483995

BIOPRO, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID00810012483995
NIH Device Record Keyec9b61a9-a610-4be9-ae6e-8d97543f09bd
Commercial Distribution StatusIn Commercial Distribution
Brand NameWRIST STAPLE INSTRUMENT TRAY
Version Model Number19480
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
GS100810012483995 [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 [WRIST STAPLE INSTRUMENT TRAY]

M20919480019480
0081001248399519480

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