Duns Number:609397224
Device Description: The function of the RAV Positioner is to provide adjustable wrist positioning, and to secu The function of the RAV Positioner is to provide adjustable wrist positioning, and to secure the wrist during arterial access procedures. The device is adjustable to accommodate the normal variation in hand sizes. It can be used on either the Right or Left wrist and is used for a limited period during the surgical procedure. The device is to be disposed of following the procedure. The RAV Wrist Positioners are non sterile and for single patient use only and are not intended to be cleaned and reused.
Catalog Number
RAVP1000
Brand Name
Rav Positioner
Version/Model Number
2030
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
May 28, 2025
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"
Yes
For Single-Use
Yes
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
FZF
Product Code Name
Splint, Extremity, Inflatable, External
Public Device Record Key
f42e03da-6454-4fd6-a14d-da6e2deb6132
Public Version Date
December 30, 2019
Public Version Number
1
DI Record Publish Date
December 20, 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 | 46 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 30 |