Catalog Number

52-1050

Brand Name

GLIDESHEATH SLENDER TIBIAL PEDAL KIT

Version/Model Number

52-1050

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

-

Product Code

DYB

Product Code Name

INTRODUCER, CATHETER

Public Device Record Key

009a41a2-0427-46b1-a7bb-3b0bda8b2be2

Public Version Date

February 21, 2020

Public Version Number

1

DI Record Publish Date

February 13, 2020

Package DI Number

30389701012347

Quantity per Package

5

Contains DI Package

00389701012346

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelfpack