Catalog Number

-

Brand Name

SMMS

Version/Model Number

SW2020

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K953829,K953829

Product Code

KCT

Product Code Name

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Public Device Record Key

c25c3d3c-99a0-422d-9d81-c1bd873fce40

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

October 07, 2016

Package DI Number

D830SW20201

Quantity per Package

125

Contains DI Package

D830SW2020

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARDBOARD BOX