Catalog Number

84-18-1000

Brand Name

ZEOS

Version/Model Number

84-18-1000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

-

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

-

Product Code

KCT

Product Code Name

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Public Device Record Key

5e9864a1-44d6-49f0-8807-ce584fb6ac72

Public Version Date

September 16, 2022

Public Version Number

6

DI Record Publish Date

August 23, 2018

Package DI Number

00812231030837

Quantity per Package

1

Contains DI Package

00812231030295

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Loaner