Tumark® Professional Q for Brevera® Standard Tumark-BREV-S-Q

GUDID 14250195611328

SOMATEX Medical Technologies GmbH

Imaging lesion localization marker, implantable

• Primary Device ID: 14250195611328
• NIH Device Record Key: b1069e28-ad1a-4aec-8fa6-37adb00e795f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tumark® Professional Q for Brevera® Standard
• Version Model Number: Tumark-BREV-S-Q
• Catalog Number: Tumark-BREV-S-Q
• 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	04250195611321 [Primary]
GS1	14250195611328 [Package]; Contains: 04250195611321; Package: [10 Units]; In Commercial Distribution
GS1	24250195611325 [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: 2018-12-27
• Device Publish Date: 2018-11-26

On-Brand Devices [Tumark® Professional Q for Brevera® Standard]

• 14250195611328: Tumark-BREV-S-Q
• 14250195612141: TUMARK-BREV-S-Q-02