Duns Number:146920025
Device Description: The TargetScan needles are used in conjunction with the biopsy planning feature of Targets The TargetScan needles are used in conjunction with the biopsy planning feature of Targetscan to target the prostate biopsy locations created in a biopsy plan.
Catalog Number
-
Brand Name
Needle Kit, TargetScan 2, 18 Gauge, 5 Pack
Version/Model Number
015-A200
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K073399
Product Code
FCG
Product Code Name
Biopsy Needle
Public Device Record Key
a4b21262-098d-4d25-9929-eec8a7334fba
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 31, 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 | 35 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |