Duns Number:831737957
Device Description: 20GA X 10CM (Breast Localization Needle With Two Wires)
Catalog Number
KOP2010
Brand Name
MPM Medical Supply (Private Label)
Version/Model Number
KOP2010
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
K863848,K863848,K863848
Product Code
GAA
Product Code Name
Needle, Aspiration And Injection, Disposable
Public Device Record Key
135c0161-6468-4982-adf4-bdf1614b8a93
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 05, 2017
Package DI Number
20859013006066
Quantity per Package
10
Contains DI Package
10859013006069
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Unit Boxes
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 14 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |