Catalog Number

SS10

Brand Name

Steriking®

Version/Model Number

SS10

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

K953776,K953776,K953776

Product Code

KCT

Product Code Name

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Public Device Record Key

c80988e5-8623-4d40-8168-78a45cdd3105

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

06438263662040

Quantity per Package

5

Contains DI Package

06438263660435

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-