Duo System Stereo

GUDID 04250195611390

SOMATEX Medical Technologies GmbH

Imaging lesion localization marker, implantable
Primary Device ID04250195611390
NIH Device Record Key62a78dbd-133b-48a3-8c14-780d9315d0ce
Commercial Distribution StatusIn Commercial Distribution
Brand NameDuo System Stereo
Version Model Number271991
Company DUNS341679629
Company NameSOMATEX Medical Technologies GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
GS104250195611383 [Primary]
GS104250195611390 [Package]
Contains: 04250195611383
Package: [10 Units]
In Commercial Distribution

FDA Product Code

MIJNeedle, Tumor Localization

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-07-30
Device Publish Date2018-06-27

On-Brand Devices [Duo System Stereo]

04250195611413271992
04250195611390271991

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