Summit Radiographic Mobile Table - Table Radiologic, stationary top (892.1980) - SUMMIT INDUSTRIES, LLC

Duns Number:130235187

Device Description: Table Radiologic, stationary top (892.1980)

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More Product Details

Catalog Number

ST1000

Brand Name

Summit Radiographic Mobile Table

Version/Model Number

ST1000

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

IXQ

Product Code Name

Table, radiographic, stationary top

Device Record Status

Public Device Record Key

d0ad23e4-6993-4e89-8a16-c78237d304c2

Public Version Date

April 29, 2021

Public Version Number

3

DI Record Publish Date

September 15, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SUMMIT INDUSTRIES, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 14
2 A medical device with a moderate to high risk that requires special controls. 10