Duns Number:042823948
Device Description: OptiLite Single Use Holmium Laser Fiber Use With Odyssey Holmium Laser Systems
Catalog Number
HLF-S550-CNV
Brand Name
Optilite
Version/Model Number
G48620
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
-
Product Code
GEX
Product Code Name
Powered laser surgical instrument
Public Device Record Key
75cf1b3c-b57f-4a1f-9568-3e32a5ea2d21
Public Version Date
April 07, 2021
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
10827002486208
Quantity per Package
3
Contains DI Package
00827002486201
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 669 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8328 |
| 3 | A medical device with high risk that requires premarket approval | 370 |
| U | Unclassified | 242 |