GUDID 00840682116527

PARALLEL DESIGN

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID00840682116527
NIH Device Record Keyd7967bbe-7443-4938-9f0d-4a0953d1d90d
Commercial Distribution StatusIn Commercial Distribution
Version Model Number3Sc-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

Operating and Storage Conditions

Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100840682116527 [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 Date2016-07-15

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

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