Catalog Number

0720658

Brand Name

Guide Glide Guidewire Introducer Needle

Version/Model Number

0720658

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

K082580,K082580,K082580

Product Code

DYB

Product Code Name

INTRODUCER, CATHETER

Public Device Record Key

2c88012b-23a8-43a7-b124-c17f95742396

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 16, 2016

Package DI Number

20801741086872

Quantity per Package

8

Contains DI Package

10801741086875

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA