Duns Number:058614483
Device Description: Non Absorbable ACL Tibial Fixation System
Catalog Number
2645SS
Brand Name
Tritis
Version/Model Number
2645SS
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
K063499
Product Code
KMF
Product Code Name
Bandage, liquid
Public Device Record Key
bb05a19b-aaf4-492d-977c-12578da93b92
Public Version Date
June 07, 2019
Public Version Number
2
DI Record Publish Date
July 29, 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 | 132 |
2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
3 | A medical device with high risk that requires premarket approval | 202 |
U | Unclassified | 40 |