Gendex GXS-700™ intraoral sensor - Size 1, Size 2 - GENDEX CORP.

Duns Number:144575763

Device Description: Size 1, Size 2

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More Product Details

Catalog Number

GXS70012

Brand Name

Gendex GXS-700™ intraoral sensor

Version/Model Number

0.822.5013

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K090458

Product Code Details

Product Code

MUH

Product Code Name

System,x-ray,extraoral source,digital

Device Record Status

Public Device Record Key

01edee36-43c6-49b3-ba63-726867714754

Public Version Date

January 31, 2022

Public Version Number

5

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GENDEX CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 35