Catalog Number

H965459830

Brand Name

angiodynamics NAMIC Disposable Inflation Device

Version/Model Number

QL2030PR

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Product Code

KOE

Product Code Name

Dilator, Urethral

Public Device Record Key

45edfc34-eb94-4a10-ad92-c876cdd4ed7f

Public Version Date

January 11, 2021

Public Version Number

6

DI Record Publish Date

September 19, 2016

Package DI Number

H965459831

Quantity per Package

10

Contains DI Package

H965459830

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-