Mammotome Revolve® lateral kit

GUDID 04547410293326

This kit is used in combination with Mammotome Revolve.

FUJIFILM CORPORATION

Stationary mammographic x-ray system, digital
Primary Device ID04547410293326
NIH Device Record Key3989339c-1ee6-4964-9766-9a2ebb710b16
Commercial Distribution StatusIn Commercial Distribution
Brand NameMammotome Revolve® lateral kit
Version Model NumberLATERAL ATTACHMENT FOR M RE E
Company DUNS713565195
Company NameFUJIFILM CORPORATION
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 Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx

Device Identifiers

Device Issuing AgencyDevice ID
GS104547410293326 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MUEFull field digital,system,x-ray,mammographic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-16

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14547410477242 - FUJIFILM2025-07-08 This product is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and en

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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