Duns Number:070556204
Device Description: Curaplex Sharps Container, 32 QT
Catalog Number
1860-08710
Brand Name
Curaplex
Version/Model Number
1860-08710
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K942054,K942054
Product Code
MMK
Product Code Name
Container, sharps
Public Device Record Key
36532124-8b0d-4f14-a901-5afd36e5981d
Public Version Date
December 11, 2019
Public Version Number
2
DI Record Publish Date
December 15, 2018
Package DI Number
00817617023656
Quantity per Package
10
Contains DI Package
00817617023649
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 |