Duns Number:103977526
Device Description: Sterile placement needle (17GA ETW x 20cm) with bone wax, (1.0 x 3mm) soft tissue gold mar Sterile placement needle (17GA ETW x 20cm) with bone wax, (1.0 x 3mm) soft tissue gold marker couple with 17mm spacer and (1.0 x 3mm) soft tissue gold marker (blue styl-loc) Sterile placement needle (17GA ETW x 20cm) with bone wax and (1.2 x 3mm) soft tissue gold marker (white styl-loc)
Catalog Number
MTNW887711
Brand Name
Coupled™ Fiducial Marker Kit
Version/Model Number
MTNW887711
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
K071614
Product Code
IYE
Product Code Name
Accelerator, linear, medical
Public Device Record Key
63037f96-35b4-400f-b9e8-c12727767b8f
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
August 02, 2017
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 | 31 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1027 |