PAD, TABLE, 5855 ORTHO TRAUMA TOP - This pad is designed for use with the Mizuho OSI - MIZUHO ORTHOPEDIC SYSTEMS, INC.

Duns Number:084527241

Device Description: This pad is designed for use with the Mizuho OSI Orthopedic Trauma Tops.Dimensions: 30.9x1 This pad is designed for use with the Mizuho OSI Orthopedic Trauma Tops.Dimensions: 30.9x19.5x3 inches.Made with Tempur-Pedic® Medical materials

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More Product Details

Catalog Number

5855-7297

Brand Name

PAD, TABLE, 5855 ORTHO TRAUMA TOP

Version/Model Number

5855-7297

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

JEA

Product Code Name

Table, Surgical With Orthopedic Accessories, Ac-Powered

Device Record Status

Public Device Record Key

7b35da49-0703-4579-a1f7-54a6452fec03

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