Mammotome revolve

GUDID 00841911101871

Remote Keypad

DEVICOR MEDICAL PRODUCTS, INC.

Mammographic stereotactic biopsy system

• Primary Device ID: 00841911101871
• NIH Device Record Key: 74ece4c2-885e-4b91-b890-7cb6bcbb0de8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mammotome revolve
• Version Model Number: MHKEYP1
• 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: true
• Serial Number: false
• 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
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between -18 Degrees Celsius and 54 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Handling Environment Temperature: Between -18 Degrees Celsius and 54 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Handling Environment Temperature: Between -18 Degrees Celsius and 54 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Handling Environment Temperature: Between -18 Degrees Celsius and 54 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Handling Environment Temperature: Between -18 Degrees Celsius and 54 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Handling Environment Temperature: Between -18 Degrees Celsius and 54 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Handling Environment Temperature: Between -18 Degrees Celsius and 54 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Handling Environment Temperature: Between -18 Degrees Celsius and 54 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Handling Environment Temperature: Between -18 Degrees Celsius and 54 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Handling Environment Temperature: Between -18 Degrees Celsius and 54 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Handling Environment Temperature: Between -18 Degrees Celsius and 54 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Handling Environment Temperature: Between -18 Degrees Celsius and 54 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Handling Environment Temperature: Between -18 Degrees Celsius and 54 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Handling Environment Temperature: Between -18 Degrees Celsius and 54 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Handling Environment Temperature: Between -18 Degrees Celsius and 54 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Handling Environment Temperature: Between -18 Degrees Celsius and 54 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Handling Environment Temperature: Between -18 Degrees Celsius and 54 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841911101871 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152989

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: 2022-02-16
• Device Publish Date: 2022-02-08

On-Brand Devices [Mammotome revolve]

• 10841911100826: Ultrasound Probe
• 10841911100819: Ultrasound Probe
• 10841911100765: Stereotactic Probe
• 10841911100758: Stereotactic Probe
• 10841911100741: Stereotactic Probe
• 10841911100734: Stereotactic Probe
• 10841911100727: Stereotactic Probe
• 10841911100710: Stereotactic Probe
• 00841911100706: Stereotactic Holster
• 00841911100690: Control Module
• 00841911100683: Ultrasound Holster
• 00841911100676: Remote Keypad
• 00841911100669: Footswitch
• 00841911100652: Cart
• 10841911100802: Probe Guide
• 10841911100796: Probe Guide
• 10841911100789: Probe Guide
• 10841911100772: Probe Guide
• 10841911102615: Stereotactic Probe
• 10841911102608: Stereotactic Probe
• 10841911102592: Stereotactic Probe
• 10841911102585: Stereotactic Probe
• 10841911102578: Stereotactic Probe
• 10841911102561: Stereotactic Probe
• 00841911102267: Control Module
• 00841911102045: Ultrasound Holster
• 00841911101895: Stereotactic Holster
• 00841911101871: Remote Keypad
• 00841911101864: Footswitch
• 00841911102328: Control Module Revolve EX
• 10841911102721: Stereotactic Probe - Non-Glass Falcon - CE
• 10841911102714: Stereotactic Probe - Non-Glass Falcon - CE
• 10841911102707: Stereotactic Probe - Non-Glass Falcon - CE
• 00841911102694: Stereotactic Probe - Non-Glass Falcon - CE
• 00841911103165: Mammotome Revolve Control Module