Duns Number:002397347
Device Description: Single Shot Nerve Block Tray (Kit) with 20 Ga. x 4 in. Stimuplex® Ultra 360® Insulated Ech Single Shot Nerve Block Tray (Kit) with 20 Ga. x 4 in. Stimuplex® Ultra 360® Insulated Echogenic Needle and Ultrasound Transducer Cover and Gel (SNB400U3)
Catalog Number
332137
Brand Name
Stimuplex®
Version/Model Number
332137
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
8e5f78a0-2c9c-406d-b5c5-46afeee0f3df
Public Version Date
January 08, 2021
Public Version Number
9
DI Record Publish Date
September 23, 2016
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 |