pjur Sampler Kit - Pjur Group Luxembourg SA

Duns Number:400744553

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More Product Details

Catalog Number

-

Brand Name

pjur Sampler Kit

Version/Model Number

pjur Sampler Kit 4 x 10ml - USA

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

K010199,K133233,K141913,K010199,K133233,K141913,K010199,K133233,K141913

Product Code Details

Product Code

NUC

Product Code Name

Lubricant, Personal

Device Record Status

Public Device Record Key

c4783466-9d65-453f-aa8f-bf6f818e74e2

Public Version Date

August 07, 2020

Public Version Number

2

DI Record Publish Date

December 04, 2018

Additional Identifiers

Package DI Number

10827160113213

Quantity per Package

6

Contains DI Package

00827160113216

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

kit

"PJUR GROUP LUXEMBOURG SA" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 58