Probe sensor assembly for GE E8CS (square) FPRSA00009

GUDID 07290016936056

UC-CARE LTD

Rectal ultrasound navigational image processor
Primary Device ID07290016936056
NIH Device Record Key59b5c62a-0d8f-4576-bbaa-294a38419b7b
Commercial Distribution StatusIn Commercial Distribution
Brand NameProbe sensor assembly for GE E8CS (square)
Version Model NumberFPRSA00009
Catalog NumberFPRSA00009
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
GS107290016936056 [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

07290016936001 - Navigo™ Workstation 2018-07-06
07290016936018 - Computer (Industrial)2018-07-06
07290016936025 - Probe sensor assembly for BK 8808 (square)2018-07-06
07290016936032 - Probe sensor assembly for BK 8818 and 8808e (squar2018-07-06
07290016936049 - Probe sensor assembly for Hitachi V53W (square)2018-07-06
07290016936056 - Probe sensor assembly for GE E8CS (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

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.