Duns Number:078352849
Device Description: "Break Away" 35 Ncm Torque Wrench - 4mm square head to fit drivers and adapters. 35Ncm max "Break Away" 35 Ncm Torque Wrench - 4mm square head to fit drivers and adapters. 35Ncm max torque.
Catalog Number
Torque Wrench 35 Ncm
Brand Name
Torque Wrench 35Ncm Breakaway
Version/Model Number
Torque Wrench 35 Ncm
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
DZN
Product Code Name
Instruments, Dental Hand
Public Device Record Key
79e8cee3-1a99-48b5-b0de-0420fc417f77
Public Version Date
February 10, 2021
Public Version Number
1
DI Record Publish Date
February 02, 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 | 405 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 536 |