Catalog Number

DVS6010

Brand Name

SUPER SHEATH 2.0SUPER SHEATH 2.0

Version/Model Number

DVS6010

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

DYB

Product Code Name

INTRODUCER, CATHETER

Public Device Record Key

194676fa-b6e0-40d1-aedc-3030b2ffa7d6

Public Version Date

September 09, 2019

Public Version Number

1

DI Record Publish Date

August 30, 2019

Package DI Number

50884908145521

Quantity per Package

5

Contains DI Package

00884908145526

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box