Tumark Eye 351290

GUDID 14250195612165

SOMATEX Medical Technologies GmbH

Radiological image marker, implantable
Primary Device ID14250195612165
NIH Device Record Key96c054c1-31f7-4b19-acab-76f55ab9a674
Commercial Distribution StatusIn Commercial Distribution
Brand NameTumark Eye
Version Model Number351290
Catalog Number351290
Company DUNS341679629
Company NameSOMATEX Medical Technologies GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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
GS104250195612168 [Primary]
GS114250195612165 [Package]
Contains: 04250195612168
Package: [10 Units]
In Commercial Distribution
GS124250195612162 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-23
Device Publish Date2025-07-15

On-Brand Devices [Tumark Eye]

04250195611376271512
04250195611345271510
14250195612172351292
14250195612165351290

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