Catalog Number

0607780

Brand Name

Peel-Apart Percutaneous Introducer Kit

Version/Model Number

0607780

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

01c61174-7683-499c-84a3-fcbfdf64048c

Public Version Date

June 07, 2019

Public Version Number

3

DI Record Publish Date

February 22, 2016

Package DI Number

10801741038355

Quantity per Package

12

Contains DI Package

00801741038358

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA