Duns Number:057007239
Device Description: Tip, Switchable, Omni HP System, 20 degree
Catalog Number
20475-HP
Brand Name
Trimedyne® OmniTip™ Switchable Tip - 20°
Version/Model Number
20475-HP
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
c741c371-95b2-4af7-bd51-0a1e489dfd30
Public Version Date
April 07, 2021
Public Version Number
3
DI Record Publish Date
July 11, 2018
Package DI Number
M47320475HP1
Quantity per Package
5
Contains DI Package
M47320475HP0
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 | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 62 |