Duns Number:017283879
Device Description: The Reinforced Anesthesia Needle is a disposable medical device that allows the user to tr The Reinforced Anesthesia Needle is a disposable medical device that allows the user to transnasally administer anesthetic solutions. The needle may be reshaped along the 3.5” length.
Catalog Number
RAN-027-2
Brand Name
Entellus Medical Reinforced Anesthesia Needle
Version/Model Number
RAN
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
Yes
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
K163435,K163435
Product Code
BSP
Product Code Name
Needle, Conduction, Anesthetic (W/Wo Introducer)
Public Device Record Key
34194f4d-a749-4a72-8b92-2d0a28407209
Public Version Date
September 28, 2020
Public Version Number
6
DI Record Publish Date
May 18, 2017
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 |