Probe sensor assembly for Philips BP10-5es FPRSA00020

GUDID 07290016936179

UC-CARE LTD

Rectal ultrasound navigational image processor
Primary Device ID07290016936179
NIH Device Record Key3f599e43-5533-4840-b3cf-02cbe0f550ed
Commercial Distribution StatusIn Commercial Distribution
Brand NameProbe sensor assembly for Philips BP10-5es
Version Model NumberFPRSA00020
Catalog NumberFPRSA00020
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
GS107290016936179 [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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