ASSURED - ASSURED hygiene pad normal - Curatex GmbH

Duns Number:316433234

Device Description: ASSURED hygiene pad normal

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More Product Details

Catalog Number

-

Brand Name

ASSURED

Version/Model Number

normal

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

EYQ

Product Code Name

Garment, Protective, For Incontinence

Device Record Status

Public Device Record Key

714963e3-f023-4c08-8ad0-5129789a127f

Public Version Date

June 26, 2020

Public Version Number

2

DI Record Publish Date

April 15, 2020

Additional Identifiers

Package DI Number

04000576013868

Quantity per Package

12

Contains DI Package

04009408027202

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"CURATEX GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1