Duns Number:482661753
Device Description: VAPR COOLPULSE Curve XL Suction Electrode Curved Suction Electrode with Integrated Handpie VAPR COOLPULSE Curve XL Suction Electrode Curved Suction Electrode with Integrated Handpiece and Hand Controls 200mm
Catalog Number
225032
Brand Name
VAPR COOLPULSE
Version/Model Number
225032
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
K143475
Product Code
GEI
Product Code Name
Electrosurgical, cutting & coagulation & accessories
Public Device Record Key
5f970d85-a9e6-4390-af4a-e2b02b4b9320
Public Version Date
February 07, 2019
Public Version Number
4
DI Record Publish Date
May 14, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 972 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6382 |
| 3 | A medical device with high risk that requires premarket approval | 20 |
| U | Unclassified | 20 |