RS85 Diagnostic Ultrasound System

GUDID 08806167788759

SAMSUNG MEDISON CO., LTD.

General-purpose ultrasound imaging system
Primary Device ID08806167788759
NIH Device Record Key645f1159-033c-4b91-a640-ecbf7fd22b73
Commercial Distribution StatusIn Commercial Distribution
Brand NameRS85 Diagnostic Ultrasound System
Version Model NumberUSS-RS85W40/US
Company DUNS687785691
Company NameSAMSUNG MEDISON 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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108806167788759 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, Ultrasonic, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-01-10
Device Publish Date2018-05-26

On-Brand Devices [RS85 Diagnostic Ultrasound System]

08809521023831USS-RS85F4F/US
08806167788759USS-RS85W40/US
08806167787424USS-RS85F40/US
08809725805363V2.04

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