Navilyst - Angiographic Guidewire, Fixed Core, J Tip - NAVILYST MEDICAL, INC.

Duns Number:809699023

Device Description: Angiographic Guidewire, Fixed Core, J Tip

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More Product Details

Catalog Number

-

Brand Name

Navilyst

Version/Model Number

97000217

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

a6e26b47-15f8-46f9-97da-c067f4af32f0

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 19, 2016

Additional Identifiers

Package DI Number

H965970002171

Quantity per Package

10

Contains DI Package

H965970002170

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX

"NAVILYST MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 71
2 A medical device with a moderate to high risk that requires special controls. 1641