Tumark Vision 271589

GUDID 04250195611093

SOMATEX Medical Technologies GmbH

Imaging lesion localization marker, implantable

• Primary Device ID: 04250195611093
• NIH Device Record Key: 01d87a42-98b8-44bc-9d89-347bdf3d6ee4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tumark Vision
• Version Model Number: 271589
• Catalog Number: 271589
• 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	04250195611086 [Primary]
GS1	04250195611093 [Package]; Contains: 04250195611086; 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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-11-25

On-Brand Devices [Tumark Vision]

• 14250195611175: 351232
• 14250195611168: 351230
• 04250195611093: 271589
• 04250195607843: 271590