AngioDynamics - 3MM J TIP, FIXED CORE, PTFE COATED - ANGIODYNAMICS, INC.

Duns Number:079105071

Device Description: 3MM J TIP, FIXED CORE, PTFE COATED

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More Product Details

Catalog Number

-

Brand Name

AngioDynamics

Version/Model Number

05500302

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 06, 2022

Issuing Agency

In HIBCC

Product Characteristics

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 Details

Product Code

DQX

Product Code Name

WIRE, GUIDE, CATHETER

Device Record Status

Public Device Record Key

4084715f-ec40-44f7-9ebb-df2b26818d70

Public Version Date

October 19, 2022

Public Version Number

5

DI Record Publish Date

September 20, 2016

Additional Identifiers

Package DI Number

H787055003022

Quantity per Package

10

Contains DI Package

H787055003021

Package Discontinue Date

October 06, 2022

Package Status

Not in Commercial Distribution

Package Type

BOX

"ANGIODYNAMICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 203