IMAGE DIAGNOSTICS INC - IDI,TABLE,VERT. TABLETOP MOVEMENT,PAIN - IMAGE DIAGNOSTICS, INC.

Duns Number:608235214

Device Description: IDI,TABLE,VERT. TABLETOP MOVEMENT,PAIN MANAGEMENT-GENERAL SURGERY-IMAGING,ASPECT 100E,230V IDI,TABLE,VERT. TABLETOP MOVEMENT,PAIN MANAGEMENT-GENERAL SURGERY-IMAGING,ASPECT 100E,230V,TABLETOP WITH FACIAL CUTOUT,#A100-2643

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More Product Details

Catalog Number

A100-2643

Brand Name

IMAGE DIAGNOSTICS INC

Version/Model Number

100E

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

IZZ

Product Code Name

Table, Radiographic, Non-Tilting, Powered

Device Record Status

Public Device Record Key

bc89ab3e-7c4f-47af-8cb7-c3a95027f170

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 18, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"IMAGE DIAGNOSTICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 30
2 A medical device with a moderate to high risk that requires special controls. 49