TUMARK Flex 351252

GUDID 14250195611212

SOMATEX Medical Technologies GmbH

Imaging lesion localization marker, implantable

• Primary Device ID: 14250195611212
• NIH Device Record Key: b36a2dd3-e202-40c1-b2ca-89031afbbff5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TUMARK Flex
• Version Model Number: 351252
• Catalog Number: 351252
• Company DUNS: 341679629
• Company Name: SOMATEX Medical Technologies GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250195611215 [Primary]
GS1	14250195611212 [Package]; Contains: 04250195611215; Package: [5 Units]; In Commercial Distribution
GS1	24250195611219 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• NEU: Marker, Radiographic, Implantable

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-02-17

On-Brand Devices [TUMARK Flex]

• 14250195611212: 351252
• 14250195611205: 351250
• 04250195604682: 271576
• 04250195602206: 271574
• 04250195604668: 271572
• 04250195604651: 271570