Catalog Number

600-10009

Brand Name

Health-Tec Sterilization Pouches

Version/Model Number

600-10009

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K143637,K143637,K143637

Product Code

JOJ

Product Code Name

Indicator, Physical/Chemical Sterilization Process

Public Device Record Key

efb1a068-9f3b-4576-9a25-944ef5eab0f7

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

January 24, 2017

Package DI Number

D773600100092

Quantity per Package

10

Contains DI Package

D773600100091

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-