Span-America - RD GM MAX 80X35X6 FGSLV - SPAN-AMERICA MEDICAL SYSTEMS, INC.

Duns Number:073704413

Device Description: RD GM MAX 80X35X6 FGSLV

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More Product Details

Catalog Number

RD82448

Brand Name

Span-America

Version/Model Number

GEOMATTRESS

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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 Details

Product Code

IKY

Product Code Name

Mattress, Flotation Therapy, Non-Powered

Device Record Status

Public Device Record Key

fe2fe260-94dc-4d37-bcfd-b3b584b47e30

Public Version Date

July 29, 2022

Public Version Number

1

DI Record Publish Date

July 21, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SPAN-AMERICA MEDICAL SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 399
2 A medical device with a moderate to high risk that requires special controls. 711