Duns Number:070556204
Device Description: Curaplex Head Immobilizer, Infant
Catalog Number
3141-91014
Brand Name
Curaplex
Version/Model Number
3141-91014
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)
Yes
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
66a8e681-a925-4e8f-9de7-ae38a9c234b2
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 04, 2017
Package DI Number
00817617023564
Quantity per Package
45
Contains DI Package
00817617023083
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 471 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 540 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 1 |