Exodus - 8F x 25cm Standard Loop Nephrostomy Drainage - NAVILYST MEDICAL, INC.

Duns Number:809699023

Device Description: 8F x 25cm Standard Loop Nephrostomy Drainage Catheter with GLYCE Hydrophilic Coating

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More Product Details

Catalog Number

-

Brand Name

Exodus

Version/Model Number

10404

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 12, 2021

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

FGE

Product Code Name

CATHETER, BILIARY, DIAGNOSTIC

Device Record Status

Public Device Record Key

e8816381-ee80-4461-947b-08a9d7808433

Public Version Date

August 18, 2021

Public Version Number

3

DI Record Publish Date

September 14, 2015

Additional Identifiers

Package DI Number

H965104041

Quantity per Package

5

Contains DI Package

H965104040

Package Discontinue Date

August 12, 2021

Package Status

Not 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