Armboard 24" Cross Table - Armboard 24" Cross Table - Qfix

Duns Number:808875397

Device Description: Armboard 24" Cross Table

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More Product Details

Catalog Number

8001217

Brand Name

Armboard 24" Cross Table

Version/Model Number

8001217

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 19, 2022

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

GDC

Product Code Name

TABLE, OPERATING-ROOM, ELECTRICAL

Device Record Status

Public Device Record Key

4f4a8be9-c0b5-4bf9-a83b-4fdbcdd8e144

Public Version Date

April 20, 2022

Public Version Number

4

DI Record Publish Date

September 13, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"QFIX" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 84
2 A medical device with a moderate to high risk that requires special controls. 998