Tumark Vision MRI

GUDID 04250195611475

SOMATEX Medical Technologies GmbH

Imaging lesion localization marker, implantable

• Primary Device ID: 04250195611475
• NIH Device Record Key: 00c55a99-8ff7-4f3b-8489-6fb2740705a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tumark Vision MRI
• Version Model Number: 601590
• Company DUNS: 341679629
• Company Name: SOMATEX Medical Technologies GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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	04250195611468 [Primary]
GS1	04250195611475 [Package]; Contains: 04250195611468; 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: 2019-01-01
• Device Publish Date: 2018-12-01

Devices Manufactured by SOMATEX Medical Technologies GmbH

• 14250195612042 - Tumark® Vision for Eviva® Standard: 2023-09-05
• 14250195612059 - Tumark® Vision for Eviva® Petite: 2023-09-05
• 14250195612066 - Tumark® Professional X for Eviva® Standard: 2023-09-05
• 14250195612073 - Tumark® Professional X for Eviva® Petite: 2023-09-05
• 14250195612080 - Tumark® Professional Q for Eviva® Standard: 2023-09-05
• 14250195612097 - Tumark® Professional Q for Eviva® Petite: 2023-09-05
• 14250195612103 - Tumark® Vision for Brevera® Standard: 2023-09-05
• 14250195612110 - Tumark® Vision for Brevera® Petite: 2023-09-05