PAD ASSEMBLY, HIP LIFTER - This pad is designed for use with the 5847-249 - MIZUHO ORTHOPEDIC SYSTEMS, INC.

Duns Number:084527241

Device Description: This pad is designed for use with the 5847-249 Hip Lifter.Dimensions: 9.5x6x1 inches.Made This pad is designed for use with the 5847-249 Hip Lifter.Dimensions: 9.5x6x1 inches.Made with Tempur-Pedic® Medical materials

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More Product Details

Catalog Number

5847-7255

Brand Name

PAD ASSEMBLY, HIP LIFTER

Version/Model Number

5847-7255

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

c17fd4f0-cd21-458a-972b-0afbb7217ef5

Public Version Date

November 19, 2020

Public Version Number

3

DI Record Publish Date

May 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