OEC

GUDID 00840682115360

Hangwei GE Medical Systems Co., Ltd.

Mobile general-purpose fluoroscopic x-ray system, digital
Primary Device ID00840682115360
NIH Device Record Key36bc25c7-2cbe-4e8f-8a49-92defcc4f5a3
Commercial Distribution StatusIn Commercial Distribution
Brand NameOEC
Version Model NumberBrivo Prime
Company DUNS654659689
Company NameHangwei GE Medical Systems Co., Ltd.
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

Phone+1(414)544-3011
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS100840682115360 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAASystem, x-ray, fluoroscopic, image-intensified

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 Date2016-05-27

On-Brand Devices [OEC]

00840682125604One
00840682145541One CFD
00840682118835Elite MiniView
00840682115438Brivo Essential
00840682115377Brivo Plus
00840682115360Brivo Prime
00195278502582MEDICAL DEVICE, UDI LABEL PLACEMENT, MiniView

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