Duns Number:039281260
Catalog Number
095193
Brand Name
LEONI™
Version/Model Number
LFS-200-SB
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
719c5962-3157-4e70-94b7-3125020e3ce4
Public Version Date
June 09, 2021
Public Version Number
1
DI Record Publish Date
June 01, 2021
Package DI Number
01816901022596
Quantity per Package
5
Contains DI Package
00816901022597
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 102 |