Duns Number:832696038
Device Description: V. Mueller LEWY TEFLON GLYCERINE MIXTURE INJECTION NEEDLE, 19GA BAYONET, LENGTH OF NEEDLE V. Mueller LEWY TEFLON GLYCERINE MIXTURE INJECTION NEEDLE, 19GA BAYONET, LENGTH OF NEEDLE FROM HUB TO END 9-3/8" (23.8CM)
Catalog Number
BE597
Brand Name
V. Mueller
Version/Model Number
BE597
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 22, 2021
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
-
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
FMI
Product Code Name
Needle, hypodermic, single lumen
Public Device Record Key
b2e30eae-55bb-4ecd-86d0-c9f6b72ef820
Public Version Date
March 04, 2022
Public Version Number
3
DI Record Publish Date
August 11, 2017
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 | 8016 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6223 |