Catalog Number

DMM.L2.A.WHT.1

Brand Name

StringKing

Version/Model Number

20267

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

Yes

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

K202607,K202607,K202607

Product Code

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

87f073bf-45bb-4a89-878b-9cfacfcbf3e6

Public Version Date

December 13, 2021

Public Version Number

1

DI Record Publish Date

December 04, 2021

Package DI Number

30195376202675

Quantity per Package

20

Contains DI Package

00195376202674

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case