Duns Number:040729840
Device Description: Sontec Cartilage Titanium Cutting Block 120 Millimeters X 120 Millimeters X 15 Millimeter Sontec Cartilage Titanium Cutting Block 120 Millimeters X 120 Millimeters X 15 Millimeters
Catalog Number
-
Brand Name
Sontec Cartilage Titanium Cutting Block
Version/Model Number
350-8453T
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"
Yes
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
LXH
Product Code Name
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Public Device Record Key
da8b3048-084a-4dce-a92c-4821158c2e4b
Public Version Date
October 10, 2022
Public Version Number
2
DI Record Publish Date
April 07, 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 | 10108 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3414 |