Subtalar Pin Guide Gen II

GUDID M20923014

BIOPRO, INC.

Orthopaedic prosthesis implantation positioning instrument, reusable
Primary Device IDM20923014
NIH Device Record Key42673f27-f43e-44e0-a952-2b4ed7f520e3
Commercial Distribution StatusIn Commercial Distribution
Brand NameSubtalar Pin Guide Gen II
Version Model Number23014
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 Datefalse
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
HIBCCM20923014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FZXGuide, Surgical, Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M20923014]

Moist Heat or Steam Sterilization


[M20923014]

Moist Heat or Steam Sterilization


[M20923014]

Moist Heat or Steam Sterilization


[M20923014]

Moist Heat or Steam Sterilization


[M20923014]

Moist Heat or Steam Sterilization


[M20923014]

Moist Heat or Steam Sterilization


[M20923014]

Moist Heat or Steam Sterilization


[M20923014]

Moist Heat or Steam Sterilization


[M20923014]

Moist Heat or Steam Sterilization


[M20923014]

Moist Heat or Steam Sterilization


[M20923014]

Moist Heat or Steam Sterilization


[M20923014]

Moist Heat or Steam Sterilization


[M20923014]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-05
Device Publish Date2023-08-28

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