FLAT ARMBOARD PAD, 1" X 24" - Made with Tempur-Pedic® Medical materials. - MIZUHO ORTHOPEDIC SYSTEMS, INC.

Duns Number:084527241

Device Description: Made with Tempur-Pedic® Medical materials.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

69441

Brand Name

FLAT ARMBOARD PAD, 1" X 24"

Version/Model Number

69441

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

Yes

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

FMP

Product Code Name

Protector, Skin Pressure

Device Record Status

Public Device Record Key

a811d60c-0ea2-446b-b1ae-b0be8ca3a6fe

Public Version Date

November 19, 2020

Public Version Number

3

DI Record Publish Date

June 30, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MIZUHO ORTHOPEDIC SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1076
2 A medical device with a moderate to high risk that requires special controls. 44