Tumark® Professional X for Eviva® Standard

GUDID 14250195612066

SOMATEX Medical Technologies GmbH

Imaging lesion localization marker, implantable

• Primary Device ID: 14250195612066
• NIH Device Record Key: 97a8fd91-070a-472f-b4ef-096aa5a8ccd2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tumark® Professional X for Eviva® Standard
• Version Model Number: TUMARK-E13-S-X-02
• 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	04250195612069 [Primary]
GS1	14250195612066 [Package]; Contains: 04250195612069; Package: [10 Units]; In Commercial Distribution
GS1	24250195612063 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-05
• Device Publish Date: 2023-08-28

On-Brand Devices [Tumark® Professional X for Eviva® Standard]

• 24250195611240: Tumark-E13-S-X
• 14250195612066: TUMARK-E13-S-X-02