Duns Number:381582196
Device Description: Bone saw with four teeth, used for cutting the ramus cortical bone. Left oriented, it is Bone saw with four teeth, used for cutting the ramus cortical bone. Left oriented, it is used to create vertical and horizontal osteotomy lines on the patient’s right mandible.
Catalog Number
F87730
Brand Name
ACTEON
Version/Model Number
03.000.418S
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
K100410
Product Code
JDX
Product Code Name
Instrument, Surgical, Sonic And Accessory/Attachment
Public Device Record Key
f56c4a51-db37-476a-ae8d-466143b21d81
Public Version Date
January 01, 2020
Public Version Number
1
DI Record Publish Date
December 24, 2019
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 | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 416 |