GUDID 00840682107129

GE PARALLEL DESIGN, INC.

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID00840682107129
NIH Device Record Keyd944d6ed-20d4-47a7-9c62-7ff4e7c172d7
Commercial Distribution StatusIn Commercial Distribution
Version Model Number8L-RS
Company DUNS623906971
Company NameGE PARALLEL DESIGN, INC.
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 HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100840682107129 [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 Number5
Public Version Date2019-01-17
Device Publish Date2016-07-15

Devices Manufactured by GE PARALLEL DESIGN, INC.

00840682142366 - NA2020-08-17
00840682108676 - NA2020-05-05
00840682113045 - NA2019-01-21
00840682105231 - NA2019-01-18
00840682105248 - NA2019-01-18
00840682105255 - NA2019-01-18
00840682115216 - NA2019-01-18
00840682105262 - NA2019-01-17

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