Catalog Number

1190106

Brand Name

PURELIFE

Version/Model Number

1190106

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 27, 2020

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KCT

Product Code Name

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Public Device Record Key

c65ece9a-5a6f-4acb-ba88-638d5741e196

Public Version Date

April 28, 2020

Public Version Number

4

DI Record Publish Date

March 17, 2017

Package DI Number

D79011901063

Quantity per Package

10

Contains DI Package

D79011901061

Package Discontinue Date

April 27, 2020

Package Status

Not in Commercial Distribution

Package Type

OUTER CASE