TUMARK Flex 271572

GUDID 04250195604668

SOMATEX Medical Technologies GmbH

Imaging lesion localization marker, implantable

• Primary Device ID: 04250195604668
• NIH Device Record Key: cff06cce-fd1f-4d13-8969-fe34e7a79478
• Commercial Distribution Discontinuation: 2018-11-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: TUMARK Flex
• Version Model Number: 271572
• Catalog Number: 271572
• Company DUNS: 341679629
• Company Name: SOMATEX Medical Technologies GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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

Customer Support Contacts

• Phone: +4930319822500
• Email: info@somatex.com
• Phone: +4930319822500
• Email: info@somatex.com
• Phone: +4930319822500
• Email: info@somatex.com
• Phone: +4930319822500
• Email: info@somatex.com
• Phone: +4930319822500
• Email: info@somatex.com
• Phone: +4930319822500
• Email: info@somatex.com
• Phone: +4930319822500
• Email: info@somatex.com
• Phone: +4930319822500
• Email: info@somatex.com
• Phone: +4930319822500
• Email: info@somatex.com
• Phone: +4930319822500
• Email: info@somatex.com
• Phone: +4930319822500
• Email: info@somatex.com
• Phone: +4930319822500
• Email: info@somatex.com
• Phone: +4930319822500
• Email: info@somatex.com
• Phone: +4930319822500
• Email: info@somatex.com
• Phone: +4930319822500
• Email: info@somatex.com
• Phone: +4930319822500
• Email: info@somatex.com
• Phone: +4930319822500
• Email: info@somatex.com
• Phone: +4930319822500
• Email: info@somatex.com
• Phone: +4930319822500
• Email: info@somatex.com
• Phone: +4930319822500
• Email: info@somatex.com
• Phone: +4930319822500
• Email: info@somatex.com
• Phone: +4930319822500
• Email: info@somatex.com
• Phone: +4930319822500
• Email: info@somatex.com
• Phone: +4930319822500
• Email: info@somatex.com
• Phone: +4930319822500
• Email: info@somatex.com
• Phone: +4930319822500
• Email: info@somatex.com
• Phone: +4930319822500
• Email: info@somatex.com
• Phone: +4930319822500
• Email: info@somatex.com
• Phone: +4930319822500
• Email: info@somatex.com
• Phone: +4930319822500
• Email: info@somatex.com
• Phone: +4930319822500
• Email: info@somatex.com
• Phone: +4930319822500
• Email: info@somatex.com
• Phone: +4930319822500
• Email: info@somatex.com
• Phone: +4930319822500
• Email: info@somatex.com
• Phone: +4930319822500
• Email: info@somatex.com
• Phone: +4930319822500
• Email: info@somatex.com
• Phone: +4930319822500
• Email: info@somatex.com
• Phone: +4930319822500
• Email: info@somatex.com
• Phone: +4930319822500
• Email: info@somatex.com
• Phone: +4930319822500
• Email: info@somatex.com
• Phone: +4930319822500
• Email: info@somatex.com
• Phone: +4930319822500
• Email: info@somatex.com
• Phone: +4930319822500
• Email: info@somatex.com
• Phone: +4930319822500
• Email: info@somatex.com
• Phone: +4930319822500
• Email: info@somatex.com
• Phone: +4930319822500
• Email: info@somatex.com
• Phone: +4930319822500
• Email: info@somatex.com
• Phone: +4930319822500
• Email: info@somatex.com
• Phone: +4930319822500
• Email: info@somatex.com
• Phone: +4930319822500
• Email: info@somatex.com
• Phone: +4930319822500
• Email: info@somatex.com
• Phone: +4930319822500
• Email: info@somatex.com
• Phone: +4930319822500
• Email: info@somatex.com

Device Dimensions

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Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250195602190 [Primary]
GS1	04250195604668 [Package]; Contains: 04250195602190; Package: [5 Units]; Discontinued: 2018-11-30; Not 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: 4
• Public Version Date: 2018-11-30
• Device Publish Date: 2015-11-03

On-Brand Devices [TUMARK Flex]

• 14250195611212: 351252
• 14250195611205: 351250
• 04250195604682: 271576
• 04250195602206: 271574
• 04250195604668: 271572
• 04250195604651: 271570