Disposable cover_60x280_narrow - Accessories of Intraoral camera, curing light - GOOD DOCTORS CO., LTD.

Duns Number:688201036

Device Description: Accessories of Intraoral camera, curing light

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More Product Details

Catalog Number

-

Brand Name

Disposable cover_60x280_narrow

Version/Model Number

IC0600250

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

Yes

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

34ebeff0-ca5b-434e-a254-db6bcae2a795

Public Version Date

December 02, 2019

Public Version Number

1

DI Record Publish Date

November 22, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GOOD DOCTORS CO., LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 16
2 A medical device with a moderate to high risk that requires special controls. 7
U Unclassified 2