Fujifilm Surgical System

GUDID 00856853006047

FUJIFILM NEW DEVELOPMENT U.S.A., INC.

Endoscopic video image processing unit
Primary Device ID00856853006047
NIH Device Record Keyde060e76-d3be-4683-a545-9c48910c50fd
Commercial Distribution StatusIn Commercial Distribution
Brand NameFujifilm Surgical System
Version Model NumberRC-4440FN
Company DUNS005065629
Company NameFUJIFILM NEW DEVELOPMENT U.S.A., 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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100856853006047 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-02-21
Device Publish Date2017-05-17

On-Brand Devices [Fujifilm Surgical System]

00856853006047RC-4440FN
00856853006030Light Source
00856853006023Video Processor
00856853006016EL-580FN

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.