Tumark Professional X-Shape 351212

GUDID 14250195611137

SOMATEX Medical Technologies GmbH

Imaging lesion localization marker, implantable
Primary Device ID14250195611137
NIH Device Record Keyf0643674-1b3e-435a-80c6-c7cc764fe4ab
Commercial Distribution StatusIn Commercial Distribution
Brand NameTumark Professional X-Shape
Version Model Number351212
Catalog Number351212
Company DUNS341679629
Company NameSOMATEX Medical Technologies GmbH
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104250195611130 [Primary]
GS114250195611137 [Package]
Contains: 04250195611130
Package: [10 Units]
In Commercial Distribution
GS124250195611134 [Package]
Package: [10 Units]
In Commercial Distribution

FDA Product Code

NEUMarker, Radiographic, Implantable

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-02-17

On-Brand Devices [Tumark Professional X-Shape]

14250195611137351212
14250195611120351210
04250195607102271551
04250195607096271549

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