Tuflex Premium

GUDID 04250195611666

SOMATEX Medical Technologies GmbH

Imaging lesion localization marker, implantable

• Primary Device ID: 04250195611666
• NIH Device Record Key: c9e1a971-fc75-4b33-80e2-f5fee83abfd3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tuflex Premium
• Version Model Number: 271651
• Company DUNS: 341679629
• Company Name: SOMATEX Medical Technologies GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	04250195611659 [Primary]
GS1	04250195611666 [Package]; Contains: 04250195611659; 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: 2020-09-08
• Device Publish Date: 2020-08-31

On-Brand Devices [Tuflex Premium]

• 04250195611680: 271652
• 04250195611666: 271651
• 04250195611642: 271650