Duns Number:017283879
Device Description: The MiniFESS Light Seeker is a fiber optic based, manually operated, reusable, sinus seeke The MiniFESS Light Seeker is a fiber optic based, manually operated, reusable, sinus seeker that emits light from the distal end. It is used during sinus procedures to illuminate anatomy and confirm the location of the paranasal sinuses using the trans-nasal approach.
Catalog Number
IS-100
Brand Name
MiniFESS Light Seeker
Version/Model Number
LP100
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K133563
Product Code
LRC
Product Code Name
Instrument, Ent Manual Surgical
Public Device Record Key
241cbf8f-f14f-479a-b728-059cc686c9b9
Public Version Date
September 21, 2020
Public Version Number
2
DI Record Publish Date
September 03, 2020
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 | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |