Catalog Number

GMW1816-29

Brand Name

Span-America

Version/Model Number

WEDGE

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

KIC

Product Code Name

Cushion, Flotation

Public Device Record Key

629eb75e-2b14-4282-adf1-6019fcbdb00e

Public Version Date

July 21, 2022

Public Version Number

1

DI Record Publish Date

July 13, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-