Duns Number:791619393
Device Description: PHANTOM ACCESSORY ARM 400MM L COLUMN - COMPLETE SET
Catalog Number
-
Brand Name
Stryker
Version/Model Number
48252234
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
FWZ
Product Code Name
Operating Room Accessories Table Tray
Public Device Record Key
ea76c359-6522-4f6a-841c-f1d473e2ea0f
Public Version Date
March 11, 2019
Public Version Number
3
DI Record Publish Date
December 01, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2398 |
2 | A medical device with a moderate to high risk that requires special controls. | 51 |