Duns Number:002397347
Device Description: Stimuplex® Ultra 22 Ga. x4 in. (100 mm) Insulated Echogenic Needle with 30° Bevel and Exte Stimuplex® Ultra 22 Ga. x4 in. (100 mm) Insulated Echogenic Needle with 30° Bevel and Extension Set (STIMAU22100/30)
Catalog Number
333656
Brand Name
Stimuplex®
Version/Model Number
333656
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
BSP
Product Code Name
NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
Public Device Record Key
8325fd5b-cbf8-42e8-b64c-57a23d9d4a0e
Public Version Date
November 12, 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 |