Mammotome elite

GUDID 10841911100864

Introducer Stylet

DEVICOR MEDICAL PRODUCTS, INC.

Side-notch biopsy gun handpiece/needle

• Primary Device ID: 10841911100864
• NIH Device Record Key: d29090c0-3bac-408b-9bce-24abe7921145
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mammotome elite
• Version Model Number: MEI10
• 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
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com

Device Dimensions

• Needle Gauge: 10 Gauge
• Needle Gauge: 10 Gauge
• Needle Gauge: 10 Gauge
• Needle Gauge: 10 Gauge
• Needle Gauge: 10 Gauge
• Needle Gauge: 10 Gauge
• Needle Gauge: 10 Gauge
• Needle Gauge: 10 Gauge
• Needle Gauge: 10 Gauge
• Needle Gauge: 10 Gauge
• Needle Gauge: 10 Gauge
• Needle Gauge: 10 Gauge
• Needle Gauge: 10 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841911100867 [Primary]
GS1	10841911100864 [Package]; Contains: 00841911100867; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153709

FDA Product Code

• KNW: Instrument, Biopsy

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: 2022-02-14
• Device Publish Date: 2022-02-04

On-Brand Devices [Mammotome elite]

• 10841911100895: Probe
• 10841911100888: Probe
• 00841911100850: Holster (tetherless vacuum-assisted biopsy system)
• 10841911100871: Introducer Stylet
• 10841911100864: Introducer Stylet
• 00841911101703: "Holster (tetherless vacuum-assisted biopsy system)"
• 00841911102823: Holster (tetherless vacuum-assisted biopsy system)
• 10841911102806: Probe
• 10841911102790: Mammotome Elite Probe