GUDID 00840682110679

GE HEALTHCARE JAPAN CORPORATION

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID00840682110679
NIH Device Record Key045a06da-1d9a-497e-a416-45d914506ff9
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberML6-15
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 Batchtrue
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

Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100840682110679 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, ultrasonic, diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-12-10
Device Publish Date2016-07-15

Devices Manufactured by GE HEALTHCARE JAPAN CORPORATION

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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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