EzCam - Accessories of Intraoral Camera - Dentall co.,Ltd.

Duns Number:690440554

Device Description: Accessories of Intraoral Camera

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More Product Details

Catalog Number

-

Brand Name

EzCam

Version/Model Number

EzCam-Cable

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

KQM

Product Code Name

Camera, Surgical And Accessories

Device Record Status

Public Device Record Key

399e1657-9737-4e7e-ad9b-6675d9bae862

Public Version Date

August 20, 2020

Public Version Number

1

DI Record Publish Date

August 12, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DENTALL CO.,LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 12
2 A medical device with a moderate to high risk that requires special controls. 6