GUDID 00840682136075

PARALLEL DESIGN

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID00840682136075
NIH Device Record Key204515ab-f535-42b9-bcca-c4af3e9423f7
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberL3-12-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

Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100840682136075 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-11-02
Device Publish Date2018-10-02

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
00840682136075 - NA2018-11-02

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