Duns Number:036985604
Device Description: Head Positioner Donut, xLarge 10 inch outer diameter x 6 inch inner diameter x 2 inch heig Head Positioner Donut, xLarge 10 inch outer diameter x 6 inch inner diameter x 2 inch height
Catalog Number
PP5225
Brand Name
Birkova
Version/Model Number
Table Pads
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LWG
Product Code Name
SURGICAL TABLE CUSHION
Public Device Record Key
756b3909-1d86-47a3-852c-1545bdd3483c
Public Version Date
July 08, 2021
Public Version Number
1
DI Record Publish Date
June 30, 2021
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 | 1528 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1557 |