Tumark Vision MRI

GUDID 04250195611475

SOMATEX Medical Technologies GmbH

Imaging lesion localization marker, implantable
Primary Device ID04250195611475
NIH Device Record Key00c55a99-8ff7-4f3b-8489-6fb2740705a5
Commercial Distribution StatusIn Commercial Distribution
Brand NameTumark Vision MRI
Version Model Number601590
Company DUNS341679629
Company NameSOMATEX Medical Technologies GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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
GS104250195611468 [Primary]
GS104250195611475 [Package]
Contains: 04250195611468
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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-01-01
Device Publish Date2018-12-01

Devices Manufactured by SOMATEX Medical Technologies GmbH

14250195612042 - Tumark® Vision for Eviva® Standard2023-09-05
14250195612059 - Tumark® Vision for Eviva® Petite2023-09-05
14250195612066 - Tumark® Professional X for Eviva® Standard2023-09-05
14250195612073 - Tumark® Professional X for Eviva® Petite2023-09-05
14250195612080 - Tumark® Professional Q for Eviva® Standard 2023-09-05
14250195612097 - Tumark® Professional Q for Eviva® Petite2023-09-05
14250195612103 - Tumark® Vision for Brevera® Standard2023-09-05
14250195612110 - Tumark® Vision for Brevera® Petite2023-09-05

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