Duns Number:001191048
Device Description: The Simpulse SOLO Wound Management Kit with VariCare Retractable Splash Shield Wound Tip
Catalog Number
0067690
Brand Name
Simpulse SOLO
Version/Model Number
0067690
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
c231793b-7158-4700-9eae-1eeac1df1d89
Public Version Date
November 06, 2020
Public Version Number
4
DI Record Publish Date
December 23, 2015
Package DI Number
20801741010181
Quantity per Package
2
Contains DI Package
10801741010184
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 |