Duns Number:136718553
Device Description: SINGLE SHOT NERVE BLOCK TRAYSonoPlex II Needle 22G x 2“ withSafersonic Probe Cover & Gel
Catalog Number
NA
Brand Name
NA
Version/Model Number
TDLS204
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
45ccbb1e-1199-46f6-959b-804dcedae679
Public Version Date
June 23, 2020
Public Version Number
1
DI Record Publish Date
June 15, 2020
Package DI Number
20858965006544
Quantity per Package
10
Contains DI Package
00858965006540
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 |