GUDID 00840682113281

GE PARALLEL DESIGN, INC.

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID00840682113281
NIH Device Record Key8a01dabb-4198-4ace-832d-b483b815bc66
Commercial Distribution StatusIn Commercial Distribution
Version Model Number3V
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100840682113281 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, ultrasonic, diagnostic

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 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

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