Duns Number:017283879
Device Description: The Portable Red LED Light Source is indicated for use in endoscopic procedures to locate, The Portable Red LED Light Source is indicated for use in endoscopic procedures to locate, illuminate within, and transilluminate across nasal and sinus structures when used with the Entellus Medical MiniFESS™ Light Seeker™. The Portable Red LED Light Source is a non-sterile device and is not intended for use in the sterile field.
Catalog Number
PRLS-100
Brand Name
Portable Red LED Light Source
Version/Model Number
PRLS
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
-
Product Code
NTN
Product Code Name
Led Light Source
Public Device Record Key
f117eac5-66d0-4c75-9d0f-f2a7c45095cb
Public Version Date
September 28, 2020
Public Version Number
1
DI Record Publish Date
September 18, 2020
Package DI Number
10857326005588
Quantity per Package
1
Contains DI Package
00857326005581
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shelf Box
| 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 |