Duns Number:015510540
Device Description: Insulated Electro-Needle for use in Regional Anesthesia, 18ga x 2.0" (51mm), Tuohy Bevel
Catalog Number
557-18-05
Brand Name
NeuroTrace
Version/Model Number
557-18-05
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K994059,K994059
Product Code
CAZ
Product Code Name
Anesthesia Conduction Kit
Public Device Record Key
97d23363-f0d8-40cf-bd2a-6506cedba7ca
Public Version Date
July 22, 2019
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
B33955718055
Quantity per Package
10
Contains DI Package
B33955718050
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 88 |