Catalog Number

68-8600-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)

Yes

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

-

Product Code

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

3da932a0-3759-40dd-aa0a-d704d5971b57

Public Version Date

July 24, 2020

Public Version Number

1

DI Record Publish Date

July 16, 2020

Package DI Number

84895237109013

Quantity per Package

1000

Contains DI Package

74895237109016

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE