Catalog Number

NAR40

Brand Name

Prosurg

Version/Model Number

NAR40

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

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

K152511,K152511

Product Code

HRX

Product Code Name

Arthroscope

Public Device Record Key

6f47a2fc-eee1-4ac3-bd7e-2bce89d567e0

Public Version Date

May 20, 2020

Public Version Number

1

DI Record Publish Date

May 12, 2020

Package DI Number

10851545007712

Quantity per Package

1

Contains DI Package

00851545007715

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pak