Catalog Number

-

Brand Name

Super Sheath

Version/Model Number

(15-722B) BT60Z11PPW038

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

K141070,K141070

Product Code

DYB

Product Code Name

INTRODUCER, CATHETER

Public Device Record Key

aac81c1d-9de6-428e-a530-7cf81f1c8998

Public Version Date

February 26, 2021

Public Version Number

7

DI Record Publish Date

September 16, 2016

Package DI Number

14543527202500

Quantity per Package

1

Contains DI Package

04543527202503

Package Discontinue Date

December 11, 2020

Package Status

Not in Commercial Distribution

Package Type

Box