Plasdent Clear Protection Sterilization Pouch - Autoclave Pouches 12" x 15", Dual Indicator - PLASDENT CORPORATION

Duns Number:190377184

Device Description: Autoclave Pouches 12" x 15", Dual Indicator (100pcs/box)

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More Product Details

Catalog Number

POH12-15

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

Product Characteristics

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 Details

Product Code

FRG

Product Code Name

Wrap, Sterilization

Device Record Status

Public Device Record Key

47282c50-0313-40e1-b674-81d21ac63fe7

Public Version Date

February 22, 2022

Public Version Number

3

DI Record Publish Date

September 21, 2018

Additional Identifiers

Package DI Number

D832POH12155

Quantity per Package

400

Contains DI Package

D832POH1215

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"PLASDENT CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 750
2 A medical device with a moderate to high risk that requires special controls. 36