Duns Number:832696038
Device Description: V. Mueller FRANKLIN-SILVERMAN BIOPSY NDL OUTER CANN LGTH 4-1/2" (11.4CM) CANNULA HUB LGTH V. Mueller FRANKLIN-SILVERMAN BIOPSY NDL OUTER CANN LGTH 4-1/2" (11.4CM) CANNULA HUB LGTH 6" (15.2CM) SPLIT NDLE HUB 6-3/4" (17.2CM)
Catalog Number
SU21061
Brand Name
V. Mueller
Version/Model Number
SU21061
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
-
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
FCG
Product Code Name
Biopsy needle
Public Device Record Key
fe8e2cc4-0bad-4dce-b274-cb0e4e56136d
Public Version Date
March 10, 2022
Public Version Number
4
DI Record Publish Date
September 24, 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 | 8016 |
2 | A medical device with a moderate to high risk that requires special controls. | 6223 |