Needle Kit, TargetScan 3, 18 Gauge, 5 Pack

GUDID 00852656007458

The TargetScan needles are used in conjunction with the biopsy planning feature of Targetscan to target the prostate biopsy locations created in a biopsy plan.

Best Nomos

Prostate biopsy needle
Primary Device ID00852656007458
NIH Device Record Key8e6344d8-87f4-43e4-9987-8d847e3e3a08
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeedle Kit, TargetScan 3, 18 Gauge, 5 Pack
Version Model Number015-A237
Company DUNS146920025
Company NameBest Nomos
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(412) 312-6700
Emailinfo@nomos.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100852656007458 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, Ultrasonic, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-31

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