Exodus - Array Multipurpose Drainage Catheter 8F x 35cm - NAVILYST MEDICAL, INC.

Duns Number:809699023

Device Description: Array Multipurpose Drainage Catheter 8F x 35cm with Tight Pigtail

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More Product Details

Catalog Number

-

Brand Name

Exodus

Version/Model Number

10521

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K152069

Product Code Details

Product Code

FGE

Product Code Name

CATHETER, BILIARY, DIAGNOSTIC

Device Record Status

Public Device Record Key

bdb570cf-fb9a-45c8-a39d-cd2bf2c4bb04

Public Version Date

March 08, 2022

Public Version Number

5

DI Record Publish Date

August 05, 2016

Additional Identifiers

Package DI Number

H965105211

Quantity per Package

5

Contains DI Package

H965105210

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