Catalog Number

GGTS06B

Brand Name

Glide & Guide Turn System Kit

Version/Model Number

GGTS06B

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

-

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

FMR

Product Code Name

Device, Transfer, Patient, Manual

Public Device Record Key

2fb9abcb-797d-4c91-a1ab-1f435743f525

Public Version Date

August 03, 2021

Public Version Number

1

DI Record Publish Date

July 26, 2021

Package DI Number

10810006684077

Quantity per Package

12

Contains DI Package

00810006684070

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Kit