Probe sensor assembly for GE BE9CS FPRSA00019

GUDID 07290016936162

UC-CARE LTD

Rectal ultrasound navigational image processor
Primary Device ID07290016936162
NIH Device Record Key56a86266-2bb5-4c19-916a-4afcd0e9e50e
Commercial Distribution StatusIn Commercial Distribution
Brand NameProbe sensor assembly for GE BE9CS
Version Model NumberFPRSA00019
Catalog NumberFPRSA00019
Company DUNS649551124
Company NameUC-CARE 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 Datefalse
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
GS107290016936162 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

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 Date2017-11-15

Devices Manufactured by UC-CARE LTD

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07290016936049 - Probe sensor assembly for Hitachi V53W (square)2018-07-06
07290016936056 - Probe sensor assembly for GE E8CS (square)2018-07-06
07290016936063 - Probe sensor assembly for BK 8667 (square)2018-07-06
07290016936070 - Probe sensor assembly for MindRay2018-07-06

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