Duns Number:381582196
Device Description: Osteotomy, osteoplasty, decorticating, drilling, shaping and smoothing of the bones andtee Osteotomy, osteoplasty, decorticating, drilling, shaping and smoothing of the bones andteeth in various surgical procedures, including but not limited to general, orthopedic,otolaryngologic, maxillofacial, oral, hand/foot, neurosurgery, spinal, andplastic/reconstructive surgery.
Catalog Number
F87991
Brand Name
ACTEON
Version/Model Number
TIP RHS3L M+ STERILE
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
-
Product Code
JDX
Product Code Name
Instrument, Surgical, Sonic And Accessory/Attachment
Public Device Record Key
f210260f-3a43-4dfc-98ba-4e77c0cdb1c6
Public Version Date
December 31, 2019
Public Version Number
1
DI Record Publish Date
December 23, 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 |