MRI Tuloc

GUDID 04250195605832

SOMATEX Medical Technologies GmbH

Imaging lesion localization marker, implantable

• Primary Device ID: 04250195605832
• NIH Device Record Key: f3b00db5-6d39-485a-ba82-7f7f377af8fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MRI Tuloc
• Version Model Number: 601651
• Company DUNS: 341679629
• Company Name: SOMATEX Medical Technologies GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	04250195601612 [Primary]
GS1	04250195605832 [Package]; Contains: 04250195601612; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• MIJ: Needle, Tumor Localization

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: 2021-11-05
• Device Publish Date: 2021-10-28

On-Brand Devices [MRI Tuloc]

• 04250195605832: 601651
• 04250195605825: 601649