Expert Tibia Nail

Basic Information

• Brand Name: Expert Tibia Nail
• Primary DI: 08903993359631
• Version / Model: TI-520-09-360
• Company Name: Auxein Medical Private Limited
• Labeler DUNS: 872194615
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-10-21
• Public Version: 1
• Public Version Date: 2020-10-29
• Public Version Status: New
• Public Device Record Key: c2167d18-be12-4e1f-97c1-690a52d82eac

Device Description

Expert Tibia Nail Ø9mm x Length 360mm, Titanium

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JDS	Nail, Fixation, Bone	Orthopedic	888.3030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56645	Tibia nail, non-sterile	A non-sterile rod made of metal or other material which, when inserted into the intramedullary canal of the tibia, acts to immobilize by holding 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 intended to be sterilized prior to use.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08903993359631	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K192003	000