AccessGUDID - DEVICE: QWIX (10381780046745)

GUDID

Device Identifier (DI) Information

Brand Name: QWIX
Version or Model: 111334SND
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 111334SND
Company Name: NEWDEAL

Primary DI Number: 10381780046745
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2027
Device Count: 1
Labeler D-U-N-S® Number*: 536935331 *Terms of Use

Device Description: The QWIX stabilization screw is a cannulated titanium alloy screw with a long non-threaded shaft, allowing optimal compression and has a self-tapping screw tip. These features enable its use in bone fixation. Its length can vary from 10 to 34mm for the 3.0mm diameter QWIX stabilization screw. The screw is cannulated in order to enable the use of a K-wire for optimal positioning. Delivered sterile.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46646	Orthopaedic bone screw, non-bioabsorbable, sterile	A small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression across bone fragments.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HWC	Screw, fixation, bone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K050346	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store in dry place.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 3mm diam. x 34mm length

Device Record Status

Public Device Record Key: b1d064a6-a4b2-44b3-bc23-6d172f1be68e
Public Version Date: February 19, 2024
Public Version Number: 5
DI Record Publish Date: October 09, 2017