Tumark® Professional X for Eviva® Petite

GUDID 14250195612073

SOMATEX Medical Technologies GmbH

Imaging lesion localization marker, implantable

• Primary Device ID: 14250195612073
• NIH Device Record Key: 1f2a7751-dff2-4aff-a854-219be236b127
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tumark® Professional X for Eviva® Petite
• Version Model Number: TUMARK-E13-P-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	04250195612076 [Primary]
GS1	14250195612073 [Package]; Contains: 04250195612076; Package: [10 Units]; In Commercial Distribution
GS1	24250195612070 [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® Petite]

• 24250195611257: Tumark-E13-P-X
• 14250195612073: TUMARK-E13-P-X-02