Catalog Number

1100ORPX010

Brand Name

WAFFLE

Version/Model Number

REV00

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)

-

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

799f8d52-f490-4fee-8c5a-d2e19798a124

Public Version Date

August 31, 2020

Public Version Number

1

DI Record Publish Date

August 21, 2020

Package DI Number

30603354200679

Quantity per Package

6

Contains DI Package

10603354200026

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box