TUMARK Flex 351250

GUDID 14250195611205

SOMATEX Medical Technologies GmbH

Imaging lesion localization marker, implantable
Primary Device ID14250195611205
NIH Device Record Key2d95e4d4-2d2a-419d-b6a2-dbb87464269d
Commercial Distribution StatusIn Commercial Distribution
Brand NameTUMARK Flex
Version Model Number351250
Catalog Number351250
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
GS104250195611208 [Primary]
GS114250195611205 [Package]
Contains: 04250195611208
Package: [5 Units]
In Commercial Distribution
GS124250195611202 [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 Flex]

14250195611212351252
14250195611205351250
04250195604682271576
04250195602206271574
04250195604668271572
04250195604651271570

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