AccessGUDID - DEVICE: Fixion Nailing System (07290109330310)

GUDID

Device Identifier (DI) Information

Brand Name: Fixion Nailing System
Version or Model: Tibial Nail
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1216028
Company Name: CARBOFIX ORTHOPEDICS LTD

Primary DI Number: 07290109330310
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 649185170 *Terms of Use

Device Description: The nail is intended for use in the fixation of long bone fractures, including diaphyseal fractures. It is indicated for shaft fractures 5cm below the surgical neck, and 5cm proximal to the distal end of the medullary canal. Includes nail cap.

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?
38152	Tibia nail	A rod made of metal or other material intended to be implanted into the intramedullary canal of the tibia to immobilize the ends of a fractured bone in position to promote healing. The device may also be used to support the bone in the presence of a pathological condition, or for knee arthrodesis. The device may be a locked or unlocked model and possess 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
Length: 280 Millimeter
Device Size Text, specify: Insertion Diameter: 10 Millimeter
Device Size Text, specify: Expanded Diameter: 16 Millimeter
Device Size Text, specify: Proximal Diameter: 12.4 Millimeter

Device Record Status

Public Device Record Key: 117a94f5-b2a6-4b9e-b5e3-0d5205259ec6
Public Version Date: December 08, 2022
Public Version Number: 3
DI Record Publish Date: October 19, 2015