Duns Number:306155953
Device Description: The Elos Torque Wrench (main body, head and Elos Driver) is made of lightweight titanium a The Elos Torque Wrench (main body, head and Elos Driver) is made of lightweight titanium and stainless steel. The Elos Torque Wrench & Driver product design, finish and quality make the tool well suited for placement and adjustment of implants, abutments and screws during surgery and other clinical procedures. The Elos Torque Wrench & Driver is easy to prepare for cleaning, disinfection and sterilization.
Catalog Number
C14569
Brand Name
Torque Wrench Kit
Version/Model Number
C14569
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
NDP
Product Code Name
Accessories, Implant, Dental, Endosseous
Public Device Record Key
82eb5cfc-9035-4900-9ef3-f9d3e1a39507
Public Version Date
August 24, 2021
Public Version Number
1
DI Record Publish Date
August 16, 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 | 222 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 142 |