Duns Number:965352946
Device Description: The Marker is a radiographic implantable marker used to mark soft tissue. It is comprised The Marker is a radiographic implantable marker used to mark soft tissue. It is comprised of a bioabsorbable spacer that holds radiopaque marker clips.
Catalog Number
-
Brand Name
BioZorb Marker GOLD
Version/Model Number
G0203
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"
-
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
K171467
Product Code
IYE
Product Code Name
Accelerator, Linear, Medical
Public Device Record Key
8270a724-074b-4921-a841-fd9d3c0f3083
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
June 08, 2018
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |