Catalog Number

-

Brand Name

Generic

Version/Model Number

551442PC

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,K953829,K953829

Product Code

KCT

Product Code Name

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Public Device Record Key

f1f27f80-ac7c-4077-8127-246a5c6cf9a6

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

February 07, 2017

Package DI Number

D830551442PC0

Quantity per Package

1

Contains DI Package

D830551442PC9

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Polybag