Catalog Number

-

Brand Name

DISPOSABLE NEEDLE

Version/Model Number

MAJ-656

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 15, 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

4e8254f1-a7b4-4153-b5c0-06add5202fba

Public Version Date

August 16, 2022

Public Version Number

4

DI Record Publish Date

September 21, 2016

Package DI Number

14953170062466

Quantity per Package

6

Contains DI Package

04953170062469

Package Discontinue Date

August 15, 2022

Package Status

Not in Commercial Distribution

Package Type

-