Hercules Medium Duty Suspension System - TRACK AND CARRIAGE ASSY, MRI CEILING SUSPENSION - AADCO MEDICAL, INC.

Duns Number:153603204

Device Description: TRACK AND CARRIAGE ASSY, MRI CEILING SUSPENSION SYSTEMS

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More Product Details

Catalog Number

-

Brand Name

Hercules Medium Duty Suspension System

Version/Model Number

OS-260NFG

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

EAK

Product Code Name

Screen, Leaded, Operator Radiation Protector

Device Record Status

Public Device Record Key

7fd19a04-36c0-4c9c-bf9f-280488f84b3f

Public Version Date

October 29, 2020

Public Version Number

1

DI Record Publish Date

October 21, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AADCO MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5
2 A medical device with a moderate to high risk that requires special controls. 6