Tumark® Vision for Brevera® Standard

GUDID 14250195612103

SOMATEX Medical Technologies GmbH

Imaging lesion localization marker, implantable

• Primary Device ID: 14250195612103
• NIH Device Record Key: 7ad91e17-a2fd-4f3c-933b-a02fee7ca077
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tumark® Vision for Brevera® Standard
• Version Model Number: TUMARK-BREV-S-V-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	04250195612106 [Primary]
GS1	14250195612103 [Package]; Contains: 04250195612106; Package: [10 Units]; In Commercial Distribution
GS1	24250195612100 [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® Vision for Brevera® Standard]

• 24250195611288: Tumark-BREV-S-Vision
• 14250195612103: TUMARK-BREV-S-V-02