KINGFA - Guangdong KINGFA SCI.&TECH. Co., Ltd.

Duns Number:543265548

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More Product Details

Catalog Number

-

Brand Name

KINGFA

Version/Model Number

KF-A F02(N)

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

K202107,K202107,K202107

Product Code Details

Product Code

FXX

Product Code Name

Mask, Surgical

Device Record Status

Public Device Record Key

56091527-66e8-4576-9344-696c94761fac

Public Version Date

February 08, 2021

Public Version Number

1

DI Record Publish Date

January 29, 2021

Additional Identifiers

Package DI Number

26973163400100

Quantity per Package

40

Contains DI Package

16973163400103

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"GUANGDONG KINGFA SCI.&TECH. CO., LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2