Duns Number:196548481
Device Description: Handpiece Set with High Flow Tip with Modified Suction Breaks
Catalog Number
0210114000S5
Brand Name
InterPulse
Version/Model Number
0210114000S5
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
22758a1c-2605-4d23-b10e-16739a60925f
Public Version Date
November 06, 2020
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
37613154076865
Quantity per Package
6
Contains DI Package
07613154076864
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2188 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3183 |
| U | Unclassified | 60 |