Catalog Number

-

Brand Name

INJECTOR

Version/Model Number

NM-101C-0427

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 29, 2022

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"

Yes

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

K993041,K993041

Product Code

FAJ

Product Code Name

Cystoscope and accessories, flexible/rigid

Public Device Record Key

70b7614d-8b05-473d-8928-7a7d7fe49030

Public Version Date

June 30, 2022

Public Version Number

5

DI Record Publish Date

September 21, 2018

Package DI Number

14953170062435

Quantity per Package

6

Contains DI Package

04953170062438

Package Discontinue Date

June 29, 2022

Package Status

Not in Commercial Distribution

Package Type

-