RS85 Diagnostic Ultrasound System

GUDID 08809725805363

V2.04

SAMSUNG MEDISON CO., LTD.

General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system
Primary Device ID08809725805363
NIH Device Record Key3266b27b-ca0f-4d56-a770-c396abba8d22
Commercial Distribution StatusIn Commercial Distribution
Brand NameRS85 Diagnostic Ultrasound System
Version Model NumberUSS-RS85F4O/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
GS108809725805363 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYNSystem, Imaging, Pulsed Doppler, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-08
Device Publish Date2021-06-30

On-Brand Devices [RS85 Diagnostic Ultrasound System]

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.