22" 5 Leg Stand Base - 22" 5 Leg Stand Base - ACCUTRON, INC.

Duns Number:088302096

Device Description: 22" 5 Leg Stand Base

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More Product Details

Catalog Number

28350-FRU

Brand Name

22" 5 Leg Stand Base

Version/Model Number

28350-FRU

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

August 31, 2199

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)

Yes

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

BXH

Product Code Name

Gauge, Gas Pressure, Cylinder/Pipeline

Device Record Status

Public Device Record Key

c31ce7d8-e273-4265-a51f-144160f7478a

Public Version Date

October 01, 2018

Public Version Number

1

DI Record Publish Date

August 31, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ACCUTRON, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 344
2 A medical device with a moderate to high risk that requires special controls. 192