Tumark Professional

GUDID 14250195611939

SOMATEX Medical Technologies GmbH

Imaging lesion localization marker, implantable

• Primary Device ID: 14250195611939
• NIH Device Record Key: a80e09d4-6b97-4bdb-9b7b-c3cd9309f0fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tumark Professional
• Version Model Number: 351282
• 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	04250195611932 [Primary]
GS1	14250195611939 [Package]; Contains: 04250195611932; 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: 2022-05-24
• Device Publish Date: 2022-05-16

On-Brand Devices [Tumark Professional]

• 04250195602275: 271557
• 04250195602268: 271559
• 04250195604644: 271565
• 04250195604637: 271560
• 14250195611939: 351282
• 14250195611922: 351280