Duns Number:117153396
Device Description: The CTE 14mm x 58mm X-Ray Template is a surgical instrument used to assist the surgeon dur The CTE 14mm x 58mm X-Ray Template is a surgical instrument used to assist the surgeon during preoperative planning.
Catalog Number
-
Brand Name
canturio™te Canary Tibial Ext 14x58mm X-Ray Template
Version/Model Number
43-5570-004-14
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
3a7914f9-7c2e-4fd1-ac05-1182ffe80b03
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 |