Duns Number:002397347
Device Description: Single Shot Nerve Block Tray (Kit) with 22 Ga. x 2 in. Stimuplex® Ultra Insulated Echogeni Single Shot Nerve Block Tray (Kit) with 22 Ga. x 2 in. Stimuplex® Ultra Insulated Echogenic Needle and Ultrasound Transducer Cover and Gel (SNB200U)
Catalog Number
332134
Brand Name
Stimuplex®
Version/Model Number
332134
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 01, 2020
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
fcba7d96-3767-4706-8cc0-8cb3a0fe9e48
Public Version Date
September 09, 2020
Public Version Number
4
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 |