Duns Number:024050887
Device Description: MasterPulse Round tip laser fiber, 365 micrometer
Catalog Number
-
Brand Name
MasterPulse Round Tip 365
Version/Model Number
SU-365-QRT
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
62bfd68f-ddb4-498a-9718-730d9657c8f2
Public Version Date
April 07, 2021
Public Version Number
2
DI Record Publish Date
June 18, 2019
Package DI Number
B145118030
Quantity per Package
5
Contains DI Package
B145118010
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 158 |