Armboard, Cross Table 22" - Armboard, Cross Table 22" - Qfix

Duns Number:808875397

Device Description: Armboard, Cross Table 22"

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More Product Details

Catalog Number

8001214

Brand Name

Armboard, Cross Table 22"

Version/Model Number

8001214

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

d806d6c2-0116-4843-942f-abec6144a339

Public Version Date

April 20, 2022

Public Version Number

4

DI Record Publish Date

April 11, 2017

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