Duns Number:018925968
Catalog Number
-
Brand Name
BioZorb
Version/Model Number
F0405
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K143484
Product Code
NEU
Product Code Name
MARKER, RADIOGRAPHIC, IMPLANTABLE
Public Device Record Key
596c672f-7462-48d3-a6c6-0bd0079fc4a5
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
April 21, 2021
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 | 130 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 311 |
| 3 | A medical device with high risk that requires premarket approval | 96 |