Duns Number:093357739
Device Description: SYSTEM TWO D3, DUAL, IL-CR & D3 SURGICAL LIGHTS, ADJ CCT
Catalog Number
-
Brand Name
SYSTEM TWO LED
Version/Model Number
SD3CD3-CNE-LCH
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K100388,K100388
Product Code
FST
Product Code Name
Light, Surgical, Fiberoptic
Public Device Record Key
70184273-e074-4c0e-ad8a-c0a9846868e2
Public Version Date
September 19, 2022
Public Version Number
2
DI Record Publish Date
March 16, 2020
Package DI Number
01816835023195
Quantity per Package
1
Contains DI Package
00816835023196
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 112 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 58 |