Duns Number:136718553
Device Description: CONTINUOUS NERVE BLOCK TRAYE-Cath with Indwelling Catheter 18G x 3-1/4" with Safersonic Pr CONTINUOUS NERVE BLOCK TRAYE-Cath with Indwelling Catheter 18G x 3-1/4" with Safersonic Probe Cover & Gel
Catalog Number
NA
Brand Name
NA
Version/Model Number
TDL134
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
4546fb82-3004-4c4c-a697-1ac064c9e205
Public Version Date
March 19, 2019
Public Version Number
1
DI Record Publish Date
March 11, 2019
Package DI Number
20858965006384
Quantity per Package
10
Contains DI Package
00858965006380
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 |