Catalog Number

-

Brand Name

N'Sure Autoclavable Pouches (4-1/4" x 12")

Version/Model Number

T820130

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"

-

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

FRC

Product Code Name

Indicator, Biological Sterilization Process

Public Device Record Key

43342888-caed-4b8b-87c2-ca723a8c40ac

Public Version Date

November 08, 2019

Public Version Number

3

DI Record Publish Date

August 22, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-