Duns Number:371402316
Device Description: The Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to The Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be used in humans to take out adequate samples of soft tissue from subdermal structures as breast, abdominal wall, thoracic wall, lymph nodes, thyroid, parotis, muscles, and liver.The Spirotome Biopsy Needle Set contains:• A two-part introducer needle that consists of a cutting cannula and a trocar stylet• A helical-tip receiving needle that has been sized to fit through the lumen of the cutting cannula• A release elementThis presentation has an external diameter of 8G (5 mm) for use under MR.
Catalog Number
SS08MR
Brand Name
Spirotome
Version/Model Number
SS08MR
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K080095,K080095
Product Code
KNW
Product Code Name
Instrument, Biopsy
Public Device Record Key
a36ae8ab-a715-4420-b00f-f1917bcf16e0
Public Version Date
October 01, 2018
Public Version Number
1
DI Record Publish Date
August 31, 2018
Package DI Number
05407005000151
Quantity per Package
5
Contains DI Package
05407005001158
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 22 |