Tumark Sphera

GUDID 14250195611816

SOMATEX Medical Technologies GmbH

Imaging lesion localization marker, implantable
Primary Device ID14250195611816
NIH Device Record Keya2b65b4b-b842-4d4e-a899-c251a0b32bb5
Commercial Distribution StatusIn Commercial Distribution
Brand NameTumark Sphera
Version Model Number351272
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
GS104250195611819 [Primary]
GS114250195611816 [Package]
Contains: 04250195611819
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 Date2021-10-18
Device Publish Date2021-10-08

On-Brand Devices [Tumark Sphera]

04250195611727271532
04250195611697271530
14250195611816351272
14250195611809351270

Trademark Results [Tumark Sphera]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TUMARK SPHERA
TUMARK SPHERA
90837691 not registered Live/Pending
SOMATEX MEDICAL TECHNOLOGIES GMBH
2021-07-20

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