Duns Number:118663297
Device Description: Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit is a needle com Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit is a needle comprised of an open tip catheter over a needle. Fascile kit is comprised of different key components required to complete the Peripheral Nerve Block procedure.
Catalog Number
500001-02
Brand Name
Fascile Continuous Peripheral Nerve Block Set
Version/Model Number
70mm, Kit without filter
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
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
K151072,K151072
Product Code
BSP
Product Code Name
Needle, Conduction, Anesthetic (W/Wo Introducer)
Public Device Record Key
6f1de0a4-0398-41ba-8b0b-f281a1f01082
Public Version Date
June 15, 2022
Public Version Number
4
DI Record Publish Date
September 26, 2016
Package DI Number
B3723000301025
Quantity per Package
5
Contains DI Package
B372500001021
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box of 5
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |