Mammotome revolve

GUDID 00841911101895

Stereotactic Holster

DEVICOR MEDICAL PRODUCTS, INC.

Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system
Primary Device ID00841911101895
NIH Device Record Key3bf97b95-5938-409c-bdbb-cc25c33b94f5
Commercial Distribution StatusIn Commercial Distribution
Brand NameMammotome revolve
Version Model NumberMSTH1
Company DUNS961832156
Company NameDEVICOR MEDICAL PRODUCTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone877-926-2666
Emailcustomersupport@mammotome.com
Phone877-926-2666
Emailcustomersupport@mammotome.com
Phone877-926-2666
Emailcustomersupport@mammotome.com
Phone877-926-2666
Emailcustomersupport@mammotome.com
Phone877-926-2666
Emailcustomersupport@mammotome.com
Phone877-926-2666
Emailcustomersupport@mammotome.com
Phone877-926-2666
Emailcustomersupport@mammotome.com
Phone877-926-2666
Emailcustomersupport@mammotome.com
Phone877-926-2666
Emailcustomersupport@mammotome.com
Phone877-926-2666
Emailcustomersupport@mammotome.com
Phone877-926-2666
Emailcustomersupport@mammotome.com
Phone877-926-2666
Emailcustomersupport@mammotome.com
Phone877-926-2666
Emailcustomersupport@mammotome.com
Phone877-926-2666
Emailcustomersupport@mammotome.com
Phone877-926-2666
Emailcustomersupport@mammotome.com
Phone877-926-2666
Emailcustomersupport@mammotome.com
Phone877-926-2666
Emailcustomersupport@mammotome.com

Operating and Storage Conditions

Handling Environment TemperatureBetween -18 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Handling Environment TemperatureBetween -18 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Handling Environment TemperatureBetween -18 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Handling Environment TemperatureBetween -18 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Handling Environment TemperatureBetween -18 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Handling Environment TemperatureBetween -18 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Handling Environment TemperatureBetween -18 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Handling Environment TemperatureBetween -18 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Handling Environment TemperatureBetween -18 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Handling Environment TemperatureBetween -18 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Handling Environment TemperatureBetween -18 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Handling Environment TemperatureBetween -18 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Handling Environment TemperatureBetween -18 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Handling Environment TemperatureBetween -18 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Handling Environment TemperatureBetween -18 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Handling Environment TemperatureBetween -18 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Handling Environment TemperatureBetween -18 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS100841911101895 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNWInstrument, Biopsy

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-16
Device Publish Date2022-02-08

On-Brand Devices [Mammotome revolve]

10841911100826Ultrasound Probe
10841911100819Ultrasound Probe
10841911100765Stereotactic Probe
10841911100758Stereotactic Probe
10841911100741Stereotactic Probe
10841911100734Stereotactic Probe
10841911100727Stereotactic Probe
10841911100710Stereotactic Probe
00841911100706Stereotactic Holster
00841911100690Control Module
00841911100683Ultrasound Holster
00841911100676Remote Keypad
00841911100669Footswitch
00841911100652Cart
10841911100802Probe Guide
10841911100796Probe Guide
10841911100789Probe Guide
10841911100772Probe Guide
10841911102615Stereotactic Probe
10841911102608Stereotactic Probe
10841911102592Stereotactic Probe
10841911102585Stereotactic Probe
10841911102578Stereotactic Probe
10841911102561Stereotactic Probe
00841911102267Control Module
00841911102045Ultrasound Holster
00841911101895Stereotactic Holster
00841911101871Remote Keypad
00841911101864Footswitch

Trademark Results [Mammotome revolve]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MAMMOTOME REVOLVE
MAMMOTOME REVOLVE
85782986 4364706 Live/Registered
Devicor Medical Products, Inc.
2012-11-19

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