Mammotome MAMMOMARK 2

GUDID 10841911100444

Biopsy Site Identifier

DEVICOR MEDICAL PRODUCTS, INC.

Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable

• Primary Device ID: 10841911100444
• NIH Device Record Key: a97a1c61-53b3-4f2b-8a61-76ed9774045c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mammotome MAMMOMARK 2
• Version Model Number: MAM3008
• Company DUNS: 961832156
• Company Name: DEVICOR MEDICAL PRODUCTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: 8 Gauge
• Needle Gauge: 8 Gauge
• Needle Gauge: 8 Gauge
• Needle Gauge: 8 Gauge
• Needle Gauge: 8 Gauge
• Needle Gauge: 8 Gauge
• Needle Gauge: 8 Gauge
• Needle Gauge: 8 Gauge
• Needle Gauge: 8 Gauge
• Needle Gauge: 8 Gauge
• Needle Gauge: 8 Gauge
• Needle Gauge: 8 Gauge
• Needle Gauge: 8 Gauge
• Needle Gauge: 8 Gauge
• Needle Gauge: 8 Gauge
• Needle Gauge: 8 Gauge
• Needle Gauge: 8 Gauge
• Needle Gauge: 8 Gauge
• Needle Gauge: 8 Gauge
• Needle Gauge: 8 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841911100447 [Primary]
GS1	10841911100444 [Package]; Contains: 00841911100447; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082278

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: 2016-11-17

On-Brand Devices [Mammotome MAMMOMARK 2]

• 10841911101656: Biopsy Site Identifier
• 10841911101649: Biopsy Site Identifier
• 10841911100444: Biopsy Site Identifier
• 10841911100437: Biopsy Site Identifier