Duns Number:801895244
Device Description: Dual-port needle with 3-finger control 12cc syringe, 1.5"
Catalog Number
-
Brand Name
Breast Aspiration Dual-Port Biopsy Needle
Version/Model Number
MX41
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
MJG
Product Code Name
Device, Percutaneous, Biopsy
Public Device Record Key
7d9aac77-f9b5-4f62-9c6f-def5ae4f8f31
Public Version Date
July 12, 2019
Public Version Number
2
DI Record Publish Date
August 14, 2018
Package DI Number
20888937014734
Quantity per Package
12
Contains DI Package
00888937014730
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1471 |
| 3 | A medical device with high risk that requires premarket approval | 2 |