Duns Number:348489386
Device Description: To prevent the bones from moving while they are being cut, a jig has been included. K-wire To prevent the bones from moving while they are being cut, a jig has been included. K-wires are passed through the jig and are then drilled into each carpal bone. The tube saw can then be passed through the centre and the cut made.
Catalog Number
OST-CBG-24
Brand Name
Osteotec CBG Guide S
Version/Model Number
OST-CBG-24
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
LXH
Product Code Name
Orthopedic Manual Surgical Instrument
Public Device Record Key
a947b31d-36e0-435a-9fe3-2e7b561fa427
Public Version Date
February 14, 2022
Public Version Number
1
DI Record Publish Date
February 04, 2022
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 | 58 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |