Duns Number:536935331
Device Description: The external protection sleeve 3 for 7.5mm screws is used during bone drilling to protect The external protection sleeve 3 for 7.5mm screws is used during bone drilling to protect the soft tissues. This external protection sleeve 3 shall be used with the internal protection sleeve 1 referenced 119171ND inserted within the drilling guide 2 referenced 119172ND.
Catalog Number
-
Brand Name
LARGE QWIX®
Version/Model Number
119173ND
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
FZX
Product Code Name
Guide, surgical, instrument
Public Device Record Key
041d0017-dffa-4bcb-a39a-39f76aa38238
Public Version Date
April 06, 2020
Public Version Number
4
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 |