Catalog Number

LTS2538Y

Brand Name

Steriking®

Version/Model Number

LTS2538

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

-

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

-

FDA Premarket Submission

K973827,K973827,K973827

Product Code

KCT

Product Code Name

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Public Device Record Key

55578a24-9b51-495d-a97e-4bd887b08a2f

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

September 26, 2016

Package DI Number

06438263644411

Quantity per Package

3

Contains DI Package

06438263660671

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-