Catalog Number

2280WCIX010

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

KIC

Product Code Name

Cushion, Flotation

Public Device Record Key

0ac16f1d-ab8d-446b-9971-ecb917a8af69

Public Version Date

June 29, 2021

Public Version Number

2

DI Record Publish Date

August 21, 2020

Package DI Number

50603354200925

Quantity per Package

12

Contains DI Package

10603354200910

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box