Duns Number:001191048
Device Description: The Simpulse SOLO System with Ultrex Retractable 1-1/4" Splash Shield Tip
Catalog Number
0067640
Brand Name
Simpulse SOLO
Version/Model Number
0067640
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
71c7543d-f60b-41f9-9367-5e1747fb96eb
Public Version Date
November 06, 2020
Public Version Number
4
DI Record Publish Date
December 23, 2015
Package DI Number
10801741010153
Quantity per Package
5
Contains DI Package
00801741010156
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BX
| 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 |