Duns Number:007941230
Device Description: FOAM POSITIONER SUPINE HEAD CRADLE FRAME CHILD POLYURETHANE FOAM BLUE DISPOSABLE NOT MADE FOAM POSITIONER SUPINE HEAD CRADLE FRAME CHILD POLYURETHANE FOAM BLUE DISPOSABLE NOT MADE WITH NATURAL RUBBER LATEX HALYARD
Catalog Number
-
Brand Name
Halyard
Version/Model Number
48718
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
d43b0cba-e55c-48c9-942a-0da28e8f0f7a
Public Version Date
October 06, 2022
Public Version Number
1
DI Record Publish Date
September 28, 2022
Package DI Number
20885632373104
Quantity per Package
36
Contains DI Package
10885632373107
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 |