Duns Number:536935331
Device Description: The internal protection sleeve 1 for 5.5mm screws is used during bone drilling to insert K The internal protection sleeve 1 for 5.5mm screws is used during bone drilling to insert K-wire and protect the soft tissues. This internal protection sleeve 1 shall be inserted within the drilling guide 2 referenced 119152ND, itself inserted within the external protection sleeve referenced 119153ND.
Catalog Number
-
Brand Name
LARGE QWIX®
Version/Model Number
119151ND
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
7b0978f1-611f-4451-bd52-87a616b343dd
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 |