Mammotome

GUDID 10841911100987

Hand-Held Probe

DEVICOR MEDICAL PRODUCTS, INC.

Side-notch biopsy gun handpiece/needle

• Primary Device ID: 10841911100987
• NIH Device Record Key: 8efed72f-73d8-4137-83d9-09e68a430858
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mammotome
• Version Model Number: MHH14
• 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: 14 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841911100980 [Primary]
GS1	10841911100987 [Package]; Contains: 00841911100980; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992813

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]

• 10841911101281: DISPOSABLE DRAPE
• 10841911101229: Vacuum Set
• 10841911100994: Hand-Held Probe
• 10841911100987: Hand-Held Probe
• 10841911100970: Hand-Held Probe
• 10841911100963: Hand-Held Probe
• 00841911100645: Holster and Cable
• 00841911100638: Software Package
• 00841911100621: Cart Upgrade
• 00841911100614: Cart
• 00841911100607: Control Module with SmartVac
• 00841911100591: Control Module with SmartVac
• 00841911100584: Control Module MR Interlock System
• 00841911100577: Holster with Keypad, Spool and Cable
• 00841911100560: Remote Keypad
• 00841911100553: Footswitch
• 00841911100546: Holster and Cable
• 10841911101243: Variable Aperture Sleeve
• 10841911101236: Variable Aperture Sleeve
• 10841911101199: Probe Guide
• 10841911101182: Probe Guide
• 10841911101175: Localization Guide
• 10841911101168: Probe Guide
• 10841911101151: Probe Guide
• 10841911101144: Probe Guide
• 10841911101137: Probe Guide
• 10841911101120: Probe Guide
• 00841911101888: Control Module MR Interlock System
• 00841911101765: Footswitch
• 00841911101840: Holster and Cable
• 00841911101833: Software Package
• 00841911101826: Cart Upgrade
• 00841911101819: Cart
• 00841911101802: Control Module with SmartVac
• 00841911101796: Control Module with SmartVac