Duns Number:070556204
Device Description: Curaplex Sharps Dart, Sharps container with one time lockable seal, 6.5 in 24ea/cs
Catalog Number
-
Brand Name
Curaplex
Version/Model Number
64250
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K150333,K150333
Product Code
MMK
Product Code Name
Container, sharps
Public Device Record Key
b0bbd3aa-1738-4263-8597-94c5ac502a73
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 22, 2017
Package DI Number
00815277027311
Quantity per Package
24
Contains DI Package
00815277027304
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 | 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 |