AccessGUDID - DEVICE: Fixion Nailing System (07290109331737)

GUDID

Device Identifier (DI) Information

Brand Name: Fixion Nailing System
Version or Model: Proximal Femur Hip Peg
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 4418110
Company Name: CARBOFIX ORTHOPEDICS LTD

Primary DI Number: 07290109331737
Issuing Agency: GS1
Commercial Distribution End Date: July 31, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 649185170 *Terms of Use

Device Description: Hip peg used with the Fixion proximal femur intramedullary nail (intended for use in the fixation of proximal fractures in the femur).

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":	No
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?
66946	Femoral neck fixation sliding bone screw	A dedicated, partially-threaded rod intended to be implanted through the sleeve of a femoral neck fixation plate/sleeve (not included) and into the neck and head of the femur to treat a trochanteric fracture. It is commonly referred to as a dynamic hip screw or lag screw, however it has no screw head, but instead includes a female thread at the proximal end to accept a compression screw.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HSB	Rod, Fixation, Intramedullary And Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Proximal Diameter: 8 x 10 Millimeter
Device Size Text, specify: Expanded Diameter: 12 Millimeter
Device Size Text, specify: Insertion Diameter: 8 Millimeter
Length: 110 Millimeter

Device Record Status

Public Device Record Key: 29ec4e47-964b-4e4e-8780-37bfad9af8e0
Public Version Date: August 01, 2024
Public Version Number: 4
DI Record Publish Date: October 22, 2015