Catalog Number

-

Brand Name

Stretch-Glide

Version/Model Number

KE-798SGA

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

IKY

Product Code Name

Mattress, Flotation Therapy, Non-Powered

Public Device Record Key

69f48a4f-110d-47f8-836a-070870eb9825

Public Version Date

June 02, 2020

Public Version Number

1

DI Record Publish Date

May 25, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-