Surgical Face Mask - Foshan Nanhai Plus Medical Co., Ltd

Duns Number:529796225

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More Product Details

Catalog Number

-

Brand Name

Surgical Face Mask

Version/Model Number

522-005

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K212610,K212610,K212610

Product Code Details

Product Code

FXX

Product Code Name

Mask, Surgical

Device Record Status

Public Device Record Key

9d992bc6-042b-41f8-8d33-8bb10a86601c

Public Version Date

March 01, 2022

Public Version Number

1

DI Record Publish Date

February 21, 2022

Additional Identifiers

Package DI Number

16973062321523

Quantity per Package

4

Contains DI Package

06973062321526

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"FOSHAN NANHAI PLUS MEDICAL 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. 62