Catalog Number

500-00011

Brand Name

Element Self Sealing Sterilization Pouch

Version/Model Number

500-00011

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K953829,K953829,K953829

Product Code

KCT

Product Code Name

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Public Device Record Key

b94e6e46-2fdf-48ac-ba90-5f3824669d1e

Public Version Date

November 26, 2019

Public Version Number

1

DI Record Publish Date

November 18, 2019

Package DI Number

D830500000112

Quantity per Package

6

Contains DI Package

D830500000111

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case