Catalog Number

80-1075

Brand Name

GLIDESHEATH SLENDER

Version/Model Number

80-1075

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)

-

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

d7b58484-3351-4003-a550-a8bd6df7cc79

Public Version Date

June 07, 2019

Public Version Number

2

DI Record Publish Date

May 23, 2018

Package DI Number

50389701012099

Quantity per Package

10

Contains DI Package

30389701012095

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton