Catalog Number

68-8522-B

Brand Name

SURGIPLUS

Version/Model Number

1

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

-

Product Code

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

1c1669d8-115d-410f-b422-c2eb5391c6b3

Public Version Date

March 09, 2021

Public Version Number

1

DI Record Publish Date

March 01, 2021

Package DI Number

00683534090107

Quantity per Package

50

Contains DI Package

00683534090114

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack