Duns Number:002397347
Device Description: Contiplex® Tuohy Ultra 360 Tray (Kit), 18 Ga. x 2 in. Insulated Echogenic Needle and Non-S Contiplex® Tuohy Ultra 360 Tray (Kit), 18 Ga. x 2 in. Insulated Echogenic Needle and Non-Stimulating Catheter - Includes UltrasoundTransducer Cover and Gel (CNB200TU3KU)
Catalog Number
332142
Brand Name
Contiplex®
Version/Model Number
332142
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OGJ
Product Code Name
Nerve block tray
Public Device Record Key
a057bf42-7951-4b9c-9c87-b4a0402b9aa3
Public Version Date
November 12, 2020
Public Version Number
6
DI Record Publish Date
April 24, 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 | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 277 |
| U | Unclassified | 2 |