Tumark Professional X-Shape 351212

GUDID 14250195611137

SOMATEX Medical Technologies GmbH

Imaging lesion localization marker, implantable

• Primary Device ID: 14250195611137
• NIH Device Record Key: f0643674-1b3e-435a-80c6-c7cc764fe4ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tumark Professional X-Shape
• Version Model Number: 351212
• Catalog Number: 351212
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250195611130 [Primary]
GS1	14250195611137 [Package]; Contains: 04250195611130; Package: [10 Units]; In Commercial Distribution
GS1	24250195611134 [Package]; 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: 2017-02-17

On-Brand Devices [Tumark Professional X-Shape]

• 14250195611137: 351212
• 14250195611120: 351210
• 04250195607102: 271551
• 04250195607096: 271549