Duns Number:146920025
Device Description: The TargetScan needles are used in conjunction with the biopsy planning feature of the Tar The TargetScan needles are used in conjunction with the biopsy planning feature of the Targetscan System to target the prostate biopsy locations created in a biopsy plan.
Catalog Number
-
Brand Name
Needle Kit, TargetScan 2, 18 Gauge, Single
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
4f7693b1-112e-4240-8476-60886e452aff
Public Version Date
August 07, 2018
Public Version Number
4
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 |