Duns Number:536935331
Device Description: The quick coupling straight handle is used with the screwdriver axes and drills with 4.5mm The quick coupling straight handle is used with the screwdriver axes and drills with 4.5mm diameter A-O attachments for motor or hand power to implant or explant the 3.0mm screws.
Catalog Number
-
Brand Name
QWIX®
Version/Model Number
119133ND
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"
Yes
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
HWE
Product Code Name
INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Public Device Record Key
1e558a0d-d9f2-43b2-8eda-7e7e39b5c8c6
Public Version Date
August 09, 2018
Public Version Number
3
DI Record Publish Date
May 26, 2017
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 | 388 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 235 |