Duns Number:027680821
Device Description: Intended to support and maintain the position of an anesthetized patient during surgery
Catalog Number
-
Brand Name
Prone Face Pillow
Version/Model Number
714100
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
Yes
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
911605df-1238-4aea-963a-dab222a56f7a
Public Version Date
March 30, 2021
Public Version Number
1
DI Record Publish Date
March 22, 2021
Package DI Number
10840113230898
Quantity per Package
12
Contains DI Package
00840113230891
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 952 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 494 |