GUDID 00840682109956

GE HEALTHCARE JAPAN CORPORATION

Rectal ultrasound imaging system transducer
Primary Device ID00840682109956
NIH Device Record Key5383cdbc-f032-4a47-85ee-faf89e021e9c
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberBE9CS
Company DUNS696021596
Company NameGE HEALTHCARE JAPAN 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 Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100840682109956 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYOSystem, imaging, pulsed echo, ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-07-15

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00195278620453 - DLIR2023-07-10 SWMD DLIR Application for Smart Subscription
00195278303196 - ASiR-V2021-09-02 ASiR-V Application Container for Smart Subscription
00195278303202 - DLIR2021-09-02 DLIR Application Container for Smart Subscription
00195278303219 - MAR2021-09-02 MAR Application Container for Smart Subscription
00840682146173 - Revolution2020-12-04 NGX Gantry common top asm with UDI

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