Duns Number:001191048
Device Description: Simpulse VariCare Wound Management Kit with VariCare Retractable Small (1.25"diameter) Spl
Catalog Number
0067030
Brand Name
Simpulse VariCare
Version/Model Number
0067030
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"
-
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
-
Product Code
FQH
Product Code Name
LAVAGE, JET
Public Device Record Key
9ef7ce7a-b8c0-471a-9c91-51e40155799e
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 05, 2015
Package DI Number
20801741065310
Quantity per Package
2
Contains DI Package
10801741065313
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 348 |
| 3 | A medical device with high risk that requires premarket approval | 18 |