Genadur - Hydrosoluble Nail Lacquer is available in a 12 mL - Polichem SA, Lussemburgo, succursale di Mendrisio

Duns Number:487972069

Device Description: Hydrosoluble Nail Lacquer is available in a 12 mL bottle with applicator brush.

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More Product Details

Catalog Number

-

Brand Name

Genadur

Version/Model Number

2

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K083087

Product Code Details

Product Code

KMF

Product Code Name

Bandage, Liquid

Device Record Status

Public Device Record Key

e773c6ef-19bd-4ce5-afcb-4e29b9eabf57

Public Version Date

August 07, 2020

Public Version Number

2

DI Record Publish Date

October 31, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"POLICHEM SA, LUSSEMBURGO, SUCCURSALE DI MENDRISIO" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1