Duns Number:149183167
Device Description: Small O-Ring
Catalog Number
680220105
Brand Name
Tritanium X
Version/Model Number
680220105
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
-
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
-
Product Code
MAX
Product Code Name
Intervertebral fusion device with bone graft, lumbar
Public Device Record Key
1d84b15d-7ea4-4183-b643-644a16114b49
Public Version Date
March 31, 2020
Public Version Number
1
DI Record Publish Date
March 23, 2020
Package DI Number
37613327366427
Quantity per Package
10
Contains DI Package
07613327366426
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2688 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5304 |
| 3 | A medical device with high risk that requires premarket approval | 86 |