Rapicide PA High-Level Disinfectant - Rapicide PA High-Level Disinfectant - MEDIVATORS INC.

Duns Number:068199363

Device Description: Rapicide PA High-Level Disinfectant

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More Product Details

Catalog Number

ML020117

Brand Name

Rapicide PA High-Level Disinfectant

Version/Model Number

ML02-0117

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 17, 2022

Issuing Agency

In GS1

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K082988,K082988

Product Code Details

Product Code

FEB

Product Code Name

Accessories, Cleaning, For Endoscope

Device Record Status

Public Device Record Key

f69edc14-554a-42cc-8d67-025759c148fc

Public Version Date

June 21, 2022

Public Version Number

9

DI Record Publish Date

April 20, 2017

Additional Identifiers

Package DI Number

30677964090173

Quantity per Package

2

Contains DI Package

00677964090172

Package Discontinue Date

June 17, 2022

Package Status

Not in Commercial Distribution

Package Type

Box

"MEDIVATORS INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2999
2 A medical device with a moderate to high risk that requires special controls. 362