Duns Number:021415875
Device Description: 2.2mm Diffusing Tip Laser Probe
Catalog Number
FFS002-01
Brand Name
FullFire® Select Diffusing Tip Laser Probe
Version/Model Number
20624-00
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 10, 2017
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K143457
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
4d104ffd-9307-4a8a-9c0c-fdacae5073d1
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 02, 2016
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 | 6 |
2 | A medical device with a moderate to high risk that requires special controls. | 111 |