US Transducer

GUDID 06944413807242

Edan Instruments, Inc.

Foetal Doppler system probe
Primary Device ID06944413807242
NIH Device Record Keya502c0cc-53a4-4039-b073-b2ee63b8624b
Commercial Distribution StatusIn Commercial Distribution
Brand NameUS Transducer
Version Model Number7 ultrasound crystals, 1MHz,pink labelcable
Company DUNS529173163
Company NameEdan Instruments, 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 Datefalse
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
GS106944413807242 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HGLTransducer, Ultrasonic, Obstetric

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-11-19
Device Publish Date2018-10-19

On-Brand Devices [US Transducer]

069444138072427 ultrasound crystals, 1MHz,pink labelcable
0694441380549112 ultrasound crystals, 1MHz
069444138054848 ultrasound crystals, 1MHz

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