Intraskan DC Plus - Intraskan DC Plus with 15" Support tube is High - SKANRAY TECHNOLOGIES LIMITED

Duns Number:863358955

Device Description: Intraskan DC Plus with 15" Support tube is High Frequency Extra oral X-Ray source to be us Intraskan DC Plus with 15" Support tube is High Frequency Extra oral X-Ray source to be used for Intra oral X-Ray in DentalRadiography for diagnostic purpose.

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More Product Details

Catalog Number

-

Brand Name

Intraskan DC Plus

Version/Model Number

303-000134-24

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K170967

Product Code Details

Product Code

EHD

Product Code Name

Unit, X-Ray, Extraoral With Timer

Device Record Status

Public Device Record Key

7a642618-8ac9-4016-a3b7-cd8733033322

Public Version Date

January 19, 2022

Public Version Number

2

DI Record Publish Date

September 26, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SKANRAY TECHNOLOGIES LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 24