Catalog Number

500-0008

Brand Name

Element Self Sealing Sterilization Pouch

Version/Model Number

500-0008

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"

Yes

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

d9a98556-3dd4-4ae4-9548-b20dc6ed7344

Public Version Date

October 23, 2020

Public Version Number

1

DI Record Publish Date

October 15, 2020

Package DI Number

D83050000081

Quantity per Package

200

Contains DI Package

D8305000008

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX