GUDID 00840682117883

PARALLEL DESIGN

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID00840682117883
NIH Device Record Key726de68b-39af-4d49-aab4-721fcb4f521b
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberM5Sc-RS
Company DUNS391532137
Company NamePARALLEL DESIGN
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 Datetrue
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
GS100840682117883 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYOSystem, imaging, pulsed echo, ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-10-06

Devices Manufactured by PARALLEL DESIGN

00840682110976 - NA2019-01-18
00840682111157 - NA2019-01-18
00840682111263 - NA2019-01-18
00840682111416 - NA2019-01-18
00840682115346 - NA2019-01-18
00840682124355 - NA2019-01-18
00840682124768 - NA2019-01-18
00840682136075 - NA2018-11-02

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