Surgical C Arm Table - Table, Surgical C-arm, Contour 115VAC - BIODEX MEDICAL SYSTEMS, INC.

Duns Number:043833813

Device Description: Table, Surgical C-arm, Contour 115VAC

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More Product Details

Catalog Number

058-840

Brand Name

Surgical C Arm Table

Version/Model Number

058-840

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

2fe81af8-3b0c-4f20-9831-9d1909e0fd30

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