Civco classic stepper sensor fixator FPRSA00022

GUDID 07290016936193

UC-CARE LTD

Rectal ultrasound navigational image processor
Primary Device ID07290016936193
NIH Device Record Key7e06e6ad-1681-435b-836e-21b5cc722918
Commercial Distribution StatusIn Commercial Distribution
Brand NameCivco classic stepper sensor fixator
Version Model NumberFPRSA00022
Catalog NumberFPRSA00022
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
GS107290016936193 [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

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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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