Reusable Biopsy Bracket

GUDID 00841912102150

45 Degree Bracket for Esaote LA 424 Ultrasound Transducers

PROTEK MEDICAL PRODUCTS, INC.

Ultrasound imaging system tracking holder, reusable
Primary Device ID00841912102150
NIH Device Record Key8f5de3c0-b4da-49f5-818b-4f805352f23f
Commercial Distribution StatusIn Commercial Distribution
Brand NameReusable Biopsy Bracket
Version Model Number6350
Company DUNS965417181
Company NamePROTEK MEDICAL PRODUCTS, 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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100841912102150 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, Ultrasonic, Diagnostic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841912102150]

High-level Disinfectant


[00841912102150]

High-level Disinfectant


[00841912102150]

High-level Disinfectant


[00841912102150]

High-level Disinfectant


[00841912102150]

High-level Disinfectant


[00841912102150]

High-level Disinfectant


[00841912102150]

High-level Disinfectant


[00841912102150]

High-level Disinfectant


[00841912102150]

High-level Disinfectant


[00841912102150]

High-level Disinfectant


[00841912102150]

High-level Disinfectant


[00841912102150]

High-level Disinfectant


[00841912102150]

High-level Disinfectant


[00841912102150]

High-level Disinfectant


[00841912102150]

High-level Disinfectant


[00841912102150]

High-level Disinfectant


[00841912102150]

High-level Disinfectant


[00841912102150]

High-level Disinfectant


[00841912102150]

High-level Disinfectant


[00841912102150]

High-level Disinfectant


[00841912102150]

High-level Disinfectant


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-12-23
Device Publish Date2016-09-16

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