Catalog Number

-

Brand Name

Super Sheath Introducer Sheath

Version/Model Number

(S-3N5/0891)BT33Z05PPW025

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"

-

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

K121504,K121504,K121504

Product Code

DYB

Product Code Name

INTRODUCER, CATHETER

Public Device Record Key

1f70af56-f6e2-4fc9-bed0-6c75e371d2e0

Public Version Date

June 07, 2019

Public Version Number

4

DI Record Publish Date

September 16, 2016

Package DI Number

74543527226881

Quantity per Package

45

Contains DI Package

14543527226889

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton