Mammotome MicroMark II

GUDID 10841911100369

Tissue Marker

DEVICOR MEDICAL PRODUCTS, INC.

Imaging lesion localization marker, implantable

• Primary Device ID: 10841911100369
• NIH Device Record Key: 16366194-609f-410e-acf8-b2ed71b56cb4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mammotome MicroMark II
• Version Model Number: C1535
• 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
• 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: 11 Gauge
• Needle Gauge: 11 Gauge
• Needle Gauge: 11 Gauge
• Needle Gauge: 11 Gauge
• Needle Gauge: 11 Gauge
• Needle Gauge: 11 Gauge
• Needle Gauge: 11 Gauge
• Needle Gauge: 11 Gauge
• Needle Gauge: 11 Gauge
• Needle Gauge: 11 Gauge
• Needle Gauge: 11 Gauge
• Needle Gauge: 11 Gauge
• Needle Gauge: 11 Gauge
• Needle Gauge: 11 Gauge
• Needle Gauge: 11 Gauge
• Needle Gauge: 11 Gauge
• Needle Gauge: 11 Gauge
• Needle Gauge: 11 Gauge
• Needle Gauge: 11 Gauge
• Needle Gauge: 11 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841911100362 [Primary]
GS1	10841911100369 [Package]; Contains: 00841911100362; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013413

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-13

On-Brand Devices [Mammotome MicroMark II]

• 10841911100390: Tissue Marker (8G)
• 10841911100383: Tissue Marker (8G)
• 10841911100376: Tissue Marker
• 10841911100369: Tissue Marker