Duns Number:264700139
Device Description: LCA100–KIT CONVERSION LCA100 SF VERS DF
Catalog Number
-
Brand Name
LUCEA LED®
Version/Model Number
ARDLCA506008A
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 29, 2020
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K113679
Product Code
FTD
Product Code Name
Lamp, surgical
Public Device Record Key
30ff48fe-7942-4892-814e-c9c3426cce30
Public Version Date
March 03, 2022
Public Version Number
5
DI Record Publish Date
September 15, 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 | 55 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1624 |