Duns Number:007941230
Device Description: FOAM POSITIONER SUPINE HEAD CRADLE FRAME ADULT POLYURETHANE FOAM BLUE DISPOSABLE NOT MADE FOAM POSITIONER SUPINE HEAD CRADLE FRAME ADULT POLYURETHANE FOAM BLUE DISPOSABLE NOT MADE WITH NATURAL RUBBER LATEX HALYARD
Catalog Number
-
Brand Name
Halyard
Version/Model Number
48719
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"
Yes
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
14ff5cf1-49b1-4e21-bd5b-f580c07c659c
Public Version Date
October 07, 2022
Public Version Number
1
DI Record Publish Date
September 29, 2022
Package DI Number
20885632373111
Quantity per Package
12
Contains DI Package
10885632373114
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 | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |