Catalog Number

DS2010100

Brand Name

Hydrophilic M-Drain® Introducer Kit

Version/Model Number

KIT-089-00

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

Yes

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

OFL

Product Code Name

Percutaneous Sheath Introducer Kit

Public Device Record Key

4a9fd392-d724-40b1-8158-c004f4a09b14

Public Version Date

December 15, 2020

Public Version Number

1

DI Record Publish Date

December 07, 2020

Package DI Number

10841268109152

Quantity per Package

10

Contains DI Package

00841268109155

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelf Box