Duns Number:147363154
Device Description: Loaner 11" Swivel Upper Arm for Universal Lateral Positioner® - No "T
Catalog Number
7526-L LOANER
Brand Name
Universal Lateral Positioner®
Version/Model Number
7526-L LOANER
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
609aad51-40d0-4a9e-bdd5-573ab458ca48
Public Version Date
July 08, 2021
Public Version Number
3
DI Record Publish Date
November 05, 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 |