Arm & Hand Surgery Table - Universal Arm and Hand Surgery Table OZ 7512875 - P AND G ENGINEERING INC

Duns Number:795690242

Device Description: Universal Arm and Hand Surgery Table OZ 7512875

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More Product Details

Catalog Number

-

Brand Name

Arm & Hand Surgery Table

Version/Model Number

OZ 7512875

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

FWZ

Product Code Name

Operating Room Accessories Table Tray

Device Record Status

Public Device Record Key

558d9949-5b0a-4faf-8bdf-570b64707b63

Public Version Date

March 05, 2020

Public Version Number

2

DI Record Publish Date

April 16, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"P AND G ENGINEERING INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10