Catalog Number

POH2-9

Brand Name

Plasdent Clear Protection Sterilization Pouch

Version/Model Number

POH

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

K172280,K172280,K172280,K172280

Product Code

FRG

Product Code Name

Wrap, Sterilization

Public Device Record Key

567cf888-81e1-4616-97ab-d329b6fac5ae

Public Version Date

February 22, 2022

Public Version Number

3

DI Record Publish Date

September 24, 2018

Package DI Number

D832POH295

Quantity per Package

4000

Contains DI Package

D832POH29

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case