Catalog Number

SS-T1

Brand Name

Steriking®

Version/Model Number

SS-T1

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

Yes

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

-

FDA Premarket Submission

K803293,K803293,K803293

Product Code

FRG

Product Code Name

Wrap, Sterilization

Public Device Record Key

8fbfde37-9972-4c02-b00e-e9cfd0f70aa5

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

September 14, 2016

Package DI Number

06438263620118

Quantity per Package

5

Contains DI Package

06438263620293

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-