Tumark Vision 351230

GUDID 14250195611168

SOMATEX Medical Technologies GmbH

Imaging lesion localization marker, implantable

• Primary Device ID: 14250195611168
• NIH Device Record Key: 4ae8fb7b-9459-47f4-9faa-0b8e683411cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tumark Vision
• Version Model Number: 351230
• Catalog Number: 351230
• Company DUNS: 341679629
• Company Name: SOMATEX Medical Technologies GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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	04250195611161 [Primary]
GS1	14250195611168 [Package]; Contains: 04250195611161; Package: [10 Units]; In Commercial Distribution
GS1	24250195611165 [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 Vision]

• 14250195611175: 351232
• 14250195611168: 351230
• 04250195611093: 271589
• 04250195607843: 271590