Safe .R World - A next generation, water based long term - Safe.R World Corporation

Duns Number:048020664

Device Description: A next generation, water based long term antimicrobial coating. Designed to inhibit the g A next generation, water based long term antimicrobial coating. Designed to inhibit the growth of microorganisms for extended periods after application.

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More Product Details

Catalog Number

PHPLUS002

Brand Name

Safe .R World

Version/Model Number

PHPLUS002

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

-

Product Code Details

Product Code

LRJ

Product Code Name

Disinfectant, Medical Devices

Device Record Status

Public Device Record Key

14a08220-c25f-4504-bcde-466883ffa7db

Public Version Date

September 01, 2022

Public Version Number

1

DI Record Publish Date

August 24, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SAFE.R WORLD CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2