Mammotome EX

GUDID 10841911100949

Probe and Vacuum Set

DEVICOR MEDICAL PRODUCTS, INC.

Side-notch biopsy gun handpiece/needle

• Primary Device ID: 10841911100949
• NIH Device Record Key: bf5dbbcd-eef9-4bfa-b3f0-2971e2b60457
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mammotome EX
• Version Model Number: HH11BEX
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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 Dimensions

• Needle Gauge: 11 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841911100942 [Primary]
GS1	10841911100949 [Package]; Contains: 00841911100942; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033700

FDA Product Code

• KNW: Instrument, Biopsy

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: 2019-07-12
• Device Publish Date: 2016-10-24

On-Brand Devices [Mammotome EX]

• 10841911100956: Probe and Vacuum Set
• 10841911100949: Probe and Vacuum Set