Duns Number:317654283
Device Description: SonoLong Curl Echo SonoLong NanoLine cannula 18G x 100mm with Tuohy SonoLong Curl Echo SonoLong NanoLine cannula 18G x 100mm with Tuohy tip and
Catalog Number
521188-34C
Brand Name
SonoLong Curl Echo
Version/Model Number
521188-34C
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
March 15, 2025
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
-
Product Code
CAZ
Product Code Name
Anesthesia conduction kit
Public Device Record Key
ba0c2d3e-fed9-451e-a032-def5d28c9bc5
Public Version Date
March 16, 2021
Public Version Number
4
DI Record Publish Date
September 07, 2016
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 | 35 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 979 |