Urology C Arm Table - Table, Urology C-Arm-800, 230 VAC - BIODEX MEDICAL SYSTEMS, INC.

Duns Number:043833813

Device Description: Table, Urology C-Arm-800, 230 VAC

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More Product Details

Catalog Number

058-805

Brand Name

Urology C Arm Table

Version/Model Number

058-805

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

IXR

Product Code Name

Table, Radiographic, Tilting

Device Record Status

Public Device Record Key

fe2c2e7d-4f39-4208-aae7-46207c66c936

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 18, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIODEX MEDICAL SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 193
2 A medical device with a moderate to high risk that requires special controls. 52