5847/5848 Pelvic Reconstruction Kit Tempur-Pedic Medical Pad Set - MIZUHO ORTHOPEDIC SYSTEMS, INC.

Duns Number:084527241

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More Product Details

Catalog Number

-

Brand Name

5847/5848 Pelvic Reconstruction Kit Tempur-Pedic Medical Pad Set

Version/Model Number

5847-218

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"

-

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

FQO

Product Code Name

Table, Operating-Room, Ac-Powered

Device Record Status

Public Device Record Key

3a82c130-73b1-4c19-81d4-f2f1a587405c

Public Version Date

May 26, 2022

Public Version Number

1

DI Record Publish Date

May 18, 2022

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