Catalog Number

-

Brand Name

DispoCap Air

Version/Model Number

100160P

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 03, 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"

-

For Single-Use

-

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

-

Product Code

FAJ

Product Code Name

Cystoscope And Accessories, Flexible/Rigid

Public Device Record Key

c011739f-0c82-4f8e-9907-f57e45b2f7c7

Public Version Date

June 10, 2022

Public Version Number

8

DI Record Publish Date

May 04, 2017

Package DI Number

20677964060292

Quantity per Package

50

Contains DI Package

00677964060298

Package Discontinue Date

May 03, 2022

Package Status

Not in Commercial Distribution

Package Type

Case