Catalog Number

600-ULT35525

Brand Name

Health-Tec Sterilization Pouch

Version/Model Number

600-ULT35525

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

-

Product Code

KCT

Product Code Name

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Public Device Record Key

c680ace4-ea8f-4dba-aadb-bbc0bfe916ae

Public Version Date

November 08, 2019

Public Version Number

3

DI Record Publish Date

January 24, 2017

Package DI Number

D773600ULT355253

Quantity per Package

5

Contains DI Package

D773600ULT355252

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-