Catalog Number

-

Brand Name

STERILUX AMD ST BULKY GZ 4.5x4.1YD 6P

Version/Model Number

15713135

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K181315,K181315

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

8bf3fbe0-682b-448a-90cd-b5b05d7ab87a

Public Version Date

September 09, 2020

Public Version Number

1

DI Record Publish Date

September 01, 2020

Package DI Number

04052199500492

Quantity per Package

120

Contains DI Package

04052199500485

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-