AccessGUDID - DEVICE: Fixion Nailing System (07290109331614)

GUDID

Device Identifier (DI) Information

Brand Name: Fixion Nailing System
Version or Model: Proximal Femur Nail
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 4360322
Company Name: CARBOFIX ORTHOPEDICS LTD

Primary DI Number: 07290109331614
Issuing Agency: GS1
Commercial Distribution End Date: May 30, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 649185170 *Terms of Use

Device Description: The proximal femur intramedullary nail is 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?
33187	Femur intramedullary nail	A rigid rod made of metal or other material intended to be implanted into the intramedullary canal of the femur to immobilize the ends of a fractured bone in position to promote healing; it is not dedicated to extension beyond the joint to an adjacent bone (i.e., not dedicated to arthrodesis/joint fusion). It may be a locked or unlocked model and may include components to assist fixation of more proximal or distal conditions. This is a single-use device.	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
Angle: 135 degree
Length: 220 Millimeter
Device Size Text, specify: Insertion Diameter: 10 Millimeter
Device Size Text, specify: Expanded Diameter: 16 Millimeter
Device Size Text, specify: Proximal Diameter: 14 Millimeter

Device Record Status

Public Device Record Key: b0723d12-d4d9-4f84-966b-135d43d5a15a
Public Version Date: February 06, 2025
Public Version Number: 5
DI Record Publish Date: October 22, 2015