Catalog Number

-

Brand Name

Super Sheath R/O

Version/Model Number

(15-962B) BT60Z11PPWX38

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

K200379,K200379

Product Code

DYB

Product Code Name

INTRODUCER, CATHETER

Public Device Record Key

f330ea6a-3b1e-4d32-af83-9945a64488ae

Public Version Date

February 10, 2021

Public Version Number

5

DI Record Publish Date

September 16, 2016

Package DI Number

14543527202661

Quantity per Package

1

Contains DI Package

04543527202664

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box