Duns Number:002397347
Device Description: Ultraplex® 22 Ga. x 3-1/8 in. (80 mm) Non-Stimulating Echogenic Needle with 30° Bevel and Ultraplex® 22 Ga. x 3-1/8 in. (80 mm) Non-Stimulating Echogenic Needle with 30° Bevel and Extension Set (UPLEX2280/30)
Catalog Number
333666
Brand Name
Ultraplex™
Version/Model Number
333666
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 27, 2019
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
38d25637-582f-4a18-864b-99ecb9bae0b7
Public Version Date
March 12, 2021
Public Version Number
5
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 |