Mammotome MR

GUDID 00841911101291

MR Biopsy Procedure Kit - Short with Targeting Set

DEVICOR MEDICAL PRODUCTS, INC.

Side-notch biopsy gun handpiece/needle

• Primary Device ID: 00841911101291
• NIH Device Record Key: d6dbd62e-d1fc-4662-b1c0-521100f36470
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mammotome MR
• Version Model Number: MRK301
• 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: true
• 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: 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	00841911101291 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042753

FDA Product Code

• KNW: Instrument, Biopsy

Sterilization

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

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 MR]

• 00841911101116: Universal Targeting Set - Long
• 00841911101109: Universal Targeting Set - Short
• 00841911101093: Universal Targeting Set - Long
• 00841911101086: Universal Targeting Set - Short
• 00841911101079: MR Targeting Set - Long
• 00841911101062: MR Targeting Set - Short
• 00841911101055: MR Targeting Set - Long
• 00841911101048: MR Targeting Set - Short
• 00841911101031: MR Bladeless Probe with Tube Set - Long
• 00841911101024: MR Bladeless Probe with Tube Set - Short
• 00841911101017: MR Bladeless Probe with Tube Set - Long
• 00841911101000: MR Bladeless Probe with Tube Set - Short
• 00841911101321: MR Biopsy Procedure Kit - Long with Targeting Set
• 00841911101314: MR Biopsy Procedure Kit - Short with Targeting Set
• 00841911101307: MR Biopsy Procedure Kit - Long with Targeting Set
• 00841911101291: MR Biopsy Procedure Kit - Short with Targeting Set
• 00841911101369: Universal Biopsy Procedure Kit - Long
• 00841911101352: Universal Biopsy Procedure Kit - Short with Targeting Set
• 00841911101345: Universal Biopsy Procedure Kit - Long with Targeting Set
• 00841911101338: Universal Biopsy Procedure Kit - Short with Targeting Set