Duns Number:136718553
Device Description: CONTINUOUS NERVE BLOCK TRAYE-Cath Plus with Indwelling Catheter 18G x 3-1/4“ with Saferson CONTINUOUS NERVE BLOCK TRAYE-Cath Plus with Indwelling Catheter 18G x 3-1/4“ with Safersonic Probe Cover & Gel
Catalog Number
NA
Brand Name
NA
Version/Model Number
TDL142
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
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
0919b90c-3438-49ba-b7c8-17e0505f5eab
Public Version Date
February 07, 2020
Public Version Number
1
DI Record Publish Date
January 30, 2020
Package DI Number
20858965006407
Quantity per Package
10
Contains DI Package
00858965006403
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 |