Duns Number:070556204
Device Description: Multi-Trauma Dressing
Catalog Number
16353
Brand Name
Curaplex
Version/Model Number
16353
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
NAB
Product Code Name
Gauze/sponge,nonresorbable for external use
Public Device Record Key
9bf9e041-4978-4381-b67b-1bd916716623
Public Version Date
June 19, 2020
Public Version Number
3
DI Record Publish Date
September 04, 2017
Package DI Number
00817617023809
Quantity per Package
50
Contains DI Package
00817617023328
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 |