Tumark Vision MRI

GUDID 04250195611475

SOMATEX Medical Technologies GmbH

Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image 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