SensorX Size #1

GUDID E247G95101

Extraoral source x-ray system

DÜRR DENTAL SE

Dental digital imaging sensor, intraoral
Primary Device IDE247G95101
NIH Device Record Keyfaff5c65-48e3-448f-a210-8ad5bd1cccfc
Commercial Distribution StatusIn Commercial Distribution
Brand NameSensorX Size #1
Version Model NumberG9510
Company DUNS315563684
Company NameDÜRR DENTAL SE
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE247G95101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MUHSystem, X-Ray, Extraoral Source, Digital

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-09
Device Publish Date2021-04-01

On-Brand Devices [SensorX Size #1]

E247G9510A1Extraoral source x-ray system
E247G95101Extraoral source x-ray system

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