PAD, 3" LEG, BERCHTOLD D850 - General surgical table pad, Made with - MIZUHO ORTHOPEDIC SYSTEMS, INC.

Duns Number:084527241

Device Description: General surgical table pad, Made with Tempur-Pedic® Medical materials.

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More Product Details

Catalog Number

CT-356169014L

Brand Name

PAD, 3" LEG, BERCHTOLD D850

Version/Model Number

CT-356169014L

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

FQO

Product Code Name

Table, Operating-Room, Ac-Powered

Device Record Status

Public Device Record Key

e0e6b2bb-b224-4e6e-a16b-42847e9264a1

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