CSD - Surgical face mask, ASTM Level 1, Blue - CHINA SURGICAL DRESSINGS CENTER CO., LTD.

Duns Number:656170990

Device Description: Surgical face mask, ASTM Level 1, Blue

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More Product Details

Catalog Number

-

Brand Name

CSD

Version/Model Number

Elastic earloop

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

K050689,K050689

Product Code Details

Product Code

FXX

Product Code Name

Mask, Surgical

Device Record Status

Public Device Record Key

f14268a6-359d-4dd3-9b26-b920b7f81826

Public Version Date

August 19, 2020

Public Version Number

1

DI Record Publish Date

August 11, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CHINA SURGICAL DRESSINGS CENTER 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. 8
U Unclassified 3