Duns Number:073260622
Catalog Number
0705-51
Brand Name
Mick 5mm gold fiduciary marker,17G,single (10pc)
Version/Model Number
0705-51
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
K890341
Product Code
IWJ
Product Code Name
System, Applicator, Radionuclide, Manual
Public Device Record Key
ac5a435f-48fa-44a2-af5d-d6a3fc020844
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 12, 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 | 13 |
2 | A medical device with a moderate to high risk that requires special controls. | 659 |