Duo System Stereo

GUDID 04250195611413

SOMATEX Medical Technologies GmbH

Imaging lesion localization marker, implantable

• Primary Device ID: 04250195611413
• NIH Device Record Key: 622a33e1-3edb-43ea-9d08-d1dc6c95fd1f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Duo System Stereo
• Version Model Number: 271992
• Company DUNS: 341679629
• Company Name: SOMATEX Medical Technologies GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250195611406 [Primary]
GS1	04250195611413 [Package]; Contains: 04250195611406; 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: 2018-07-30
• Device Publish Date: 2018-06-27

On-Brand Devices [Duo System Stereo]

• 04250195611413: 271992
• 04250195611390: 271991