Duns Number:070556204
Device Description: 11 Point Strap, Black
Catalog Number
14130
Brand Name
Curaplex
Version/Model Number
14130
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
-
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
6e9cca00-3f79-4fce-a6df-17e42a9f70cf
Public Version Date
February 21, 2019
Public Version Number
4
DI Record Publish Date
September 04, 2017
Package DI Number
00817617023755
Quantity per Package
25
Contains DI Package
00817617023274
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 |