Tumark Eye 351292

GUDID 14250195612172

SOMATEX Medical Technologies GmbH

Radiological image marker, implantable

• Primary Device ID: 14250195612172
• NIH Device Record Key: dfb1c15a-fb86-445d-b039-86eb7b867fb8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tumark Eye
• Version Model Number: 351292
• Catalog Number: 351292
• 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	04250195612175 [Primary]
GS1	14250195612172 [Package]; Contains: 04250195612175; Package: [10 Units]; In Commercial Distribution
GS1	24250195612179 [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: 2025-07-23
• Device Publish Date: 2025-07-15

On-Brand Devices [Tumark Eye]

• 04250195611376: 271512
• 04250195611345: 271510
• 14250195612172: 351292
• 14250195612165: 351290