Duns Number:175697908
Device Description: Intended to provide tissue retraction and surgical site illumination from a high intensity Intended to provide tissue retraction and surgical site illumination from a high intensity light source. Additionally, the device is intended to remove smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
Catalog Number
A155TSE
Brand Name
Eikon LT Adapt Smoke Evacuation
Version/Model Number
A155TSE
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"
Yes
For Single-Use
-
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
GAD
Product Code Name
Retractor
Public Device Record Key
686c40f8-2f58-489d-8925-7182463ecded
Public Version Date
August 20, 2021
Public Version Number
3
DI Record Publish Date
August 09, 2019
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 | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 28 |