Tumark® Professional X for Brevera® Petite Tumark-BREV-P-X

GUDID 24250195611318

SOMATEX Medical Technologies GmbH

Imaging lesion localization marker, implantable

• Primary Device ID: 24250195611318
• NIH Device Record Key: 233b38cd-b1ba-4297-8bd3-ce0e81c8c10d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tumark® Professional X for Brevera® Petite
• Version Model Number: Tumark-BREV-P-X
• Catalog Number: Tumark-BREV-P-X
• 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	04250195611314 [Primary]
GS1	14250195611311 [Package]; Contains: 04250195611314; Package: [10 Units]; In Commercial Distribution
GS1	24250195611318 [Package]; Contains: 14250195611311; 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 X for Brevera® Petite]

• 24250195611318: Tumark-BREV-P-X
• 14250195612134: TUMARK-BREV-P-X-02