Catalog Number

-

Brand Name

Arcwave by pjur

Version/Model Number

Arcwave by pjur 10ml

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K010199,K010199,K010199

Product Code

NUC

Product Code Name

Lubricant, Personal

Public Device Record Key

37b0fb29-5293-4536-8b3c-bff6efe1ac92

Public Version Date

August 07, 2020

Public Version Number

2

DI Record Publish Date

January 08, 2020

Package DI Number

40827160114211

Quantity per Package

500

Contains DI Package

10827160114210

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case