Mammotome elite

GUDID 00841911100850

Holster (tetherless vacuum-assisted biopsy system)

DEVICOR MEDICAL PRODUCTS, INC.

Mammographic stereotactic biopsy system

• Primary Device ID: 00841911100850
• NIH Device Record Key: bedaff40-f2ba-49d3-8f8d-6e71f20d0c87
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mammotome elite
• Version Model Number: MEH1
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841911100850 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153709

FDA Product Code

• KNW: Instrument, Biopsy

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-28

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