Reusable Stainless Steel Biopsy Bracket

GUDID 00841912102259

Stainless Steel Bracket for Philips C7-3 Ultrasound Transducers

PROTEK MEDICAL PRODUCTS, INC.

Ultrasound imaging system tracking holder, reusable
Primary Device ID00841912102259
NIH Device Record Keye2280f20-c82f-40ba-a168-495069dd438c
Commercial Distribution StatusIn Commercial Distribution
Brand NameReusable Stainless Steel Biopsy Bracket
Version Model Number6394
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
GS100841912102259 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, Ultrasonic, Diagnostic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841912102259]

Moist Heat or Steam Sterilization


[00841912102259]

Moist Heat or Steam Sterilization


[00841912102259]

Moist Heat or Steam Sterilization


[00841912102259]

Moist Heat or Steam Sterilization


[00841912102259]

Moist Heat or Steam Sterilization


[00841912102259]

Moist Heat or Steam Sterilization


[00841912102259]

Moist Heat or Steam Sterilization


[00841912102259]

Moist Heat or Steam Sterilization


[00841912102259]

Moist Heat or Steam Sterilization


[00841912102259]

Moist Heat or Steam Sterilization


[00841912102259]

Moist Heat or Steam Sterilization


[00841912102259]

Moist Heat or Steam Sterilization


[00841912102259]

Moist Heat or Steam Sterilization


[00841912102259]

Moist Heat or Steam Sterilization


[00841912102259]

Moist Heat or Steam Sterilization


[00841912102259]

Moist Heat or Steam Sterilization


[00841912102259]

Moist Heat or Steam Sterilization


[00841912102259]

Moist Heat or Steam Sterilization


[00841912102259]

Moist Heat or Steam Sterilization


[00841912102259]

Moist Heat or Steam Sterilization


[00841912102259]

Moist Heat or Steam Sterilization


Device Entry Metadata

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

On-Brand Devices [Reusable Stainless Steel Biopsy Bracket]

00841912102259Stainless Steel Bracket for Philips C7-3 Ultrasound Transducers
00841912102037Stainless Steel Bracket for Samsung Medison C2-5 Ultrasound Transducers

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