Duns Number:392994778
Device Description: Whitacre spinal needle (with introducer) - 25G - L. 90mm (20G - L. 38mm)
Catalog Number
00018105
Brand Name
VYGON
Version/Model Number
181.05
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"
-
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
5c216656-167a-49a4-80b2-7663a32f0e9f
Public Version Date
May 09, 2022
Public Version Number
1
DI Record Publish Date
April 29, 2022
Package DI Number
53660812139699
Quantity per Package
40
Contains DI Package
33660812139695
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 195 |