Duns Number:117153396
Device Description: CTE Instruments are stored in an Instrument Tray which has no contact with the patient. W CTE Instruments are stored in an Instrument Tray which has no contact with the patient. Within the tray, the Instruments are held in place by reusable Modular Brackets that contact the Instruments during sterilization and storage (while inside the Tray), but have no patient contact themselves.
Catalog Number
-
Brand Name
canturio™ te Modular Bracket, Impaction Sleeve
Version/Model Number
110044505
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
DEN200064
Product Code
QPP
Product Code Name
Implantable Post-Surgical Kinematic Measurement Knee Device
Public Device Record Key
f90716c3-844b-4e1f-991c-8762ef002690
Public Version Date
September 30, 2021
Public Version Number
1
DI Record Publish Date
September 22, 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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 12 |