Tuflex Premium

GUDID 04250195611642

SOMATEX Medical Technologies GmbH

Imaging lesion localization marker, implantable
Primary Device ID04250195611642
NIH Device Record Key991a4357-73ac-4538-835a-37f1ca854361
Commercial Distribution StatusIn Commercial Distribution
Brand NameTuflex Premium
Version Model Number271650
Company DUNS341679629
Company NameSOMATEX Medical Technologies GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
GS104250195611635 [Primary]
GS104250195611642 [Package]
Contains: 04250195611635
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 Date2020-09-08
Device Publish Date2020-08-31

On-Brand Devices [Tuflex Premium]

04250195611680271652
04250195611666271651
04250195611642271650

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