Whicam Story3_wired - Intraoral camera - GOOD DOCTORS CO., LTD.

Duns Number:688201036

Device Description: Intraoral camera

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More Product Details

Catalog Number

-

Brand Name

Whicam Story3_wired

Version/Model Number

IC-WHW61

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

2cf3582d-54e7-49d6-9e88-51054abb77e1

Public Version Date

November 07, 2019

Public Version Number

1

DI Record Publish Date

October 30, 2019

Additional Identifiers

Package DI Number

18800025400026

Quantity per Package

1

Contains DI Package

08800025400029

Package Discontinue Date

-

Package Status

In Commercial Distribution

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