Catalog Number

-

Brand Name

Surgical Tie-On Mask

Version/Model Number

GCS

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"

-

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

K133070,K133070,K133070

Product Code

FXX

Product Code Name

Mask, surgical

Public Device Record Key

370fd7dd-c17e-4199-80de-4a553bec48ce

Public Version Date

May 16, 2022

Public Version Number

1

DI Record Publish Date

May 06, 2022

Package DI Number

50732224120503

Quantity per Package

6

Contains DI Package

10732224120499

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-