Catalog Number

DVS505

Brand Name

SUPER SHEATH 2.1SUPER SHEATH 2.1

Version/Model Number

DVS505

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

1b947f65-5fb4-47eb-b915-ba7c382f8b0d

Public Version Date

September 02, 2019

Public Version Number

1

DI Record Publish Date

August 24, 2019

Package DI Number

50884908145965

Quantity per Package

5

Contains DI Package

00884908145960

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box