Duns Number:196548481
Device Description: Handpiece Set with Coaxial Fan Spray Tip
Catalog Number
0210918100
Brand Name
InterPulse
Version/Model Number
0210918100
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 01, 2017
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
de885d1a-db80-40f1-b224-19e19b0f8393
Public Version Date
November 06, 2020
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
37613154547259
Quantity per Package
6
Contains DI Package
07613154547258
Package Discontinue Date
July 01, 2017
Package Status
Not 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 |