Duns Number:147363154
Device Description: ULP Standard with 11" Horizontal Adj Swivel Arms
Catalog Number
1092-SP 11" SWIVEL KIT
Brand Name
Universal Lateral Positioner®
Version/Model Number
1092-SP 11" SWIVEL KIT
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
CCX
Product Code Name
Support, Patient Position
Public Device Record Key
9f20e4b3-2731-450f-8ac8-f24cd0976d2c
Public Version Date
July 08, 2021
Public Version Number
3
DI Record Publish Date
September 19, 2019
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 | 518 |