Mammotome MammoTest

GUDID 00841911101581

Stereotactic X-Ray Breast Biopsy Table System

DEVICOR MEDICAL PRODUCTS, INC.

Mammographic stereotactic biopsy system

• Primary Device ID: 00841911101581
• NIH Device Record Key: b0da8867-b82c-4b09-a3dd-61b5506b57fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mammotome MammoTest
• Version Model Number: MMT100
• Company DUNS: 961832156
• Company Name: DEVICOR MEDICAL PRODUCTS, INC.
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 877-926-2666
• Email: customersupport@mammotome.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841911101581 [Primary]

FDA Product Code

• IZH: System, X-Ray, Mammographic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-11-17

On-Brand Devices [Mammotome MammoTest]

• 00841911101581: Stereotactic X-Ray Breast Biopsy Table System
• 00841911101215: Probe Guide Holder Lateral
• 00841911101758: Fischer Probe Guide Holder
• 00841911100539: Stereotactic Adapter