Duns Number:136718553
Device Description: CONTINUOUS NERVE BLOCK TRAYE-Cath Tray 18G x 4'' (100mm) indwelling catheter, SonoPlex 21G CONTINUOUS NERVE BLOCK TRAYE-Cath Tray 18G x 4'' (100mm) indwelling catheter, SonoPlex 21G x 4-2/3'' echogenic needle with distal opening, E-Cath 20G echogenic Self-Priming catheter with open tip and fixed injection tubing, FixoCath catheter fixation device and Safersonic Probe Cover & Gel[10/box]
Catalog Number
-
Brand Name
N/A
Version/Model Number
TDL135
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
-
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
2203f1b9-639e-433e-a3de-19dcc2c9b858
Public Version Date
May 19, 2021
Public Version Number
1
DI Record Publish Date
May 11, 2021
Package DI Number
20858965006650
Quantity per Package
10
Contains DI Package
00858965006656
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 41 |