2.7/3.5mm Wise-Lock Dorsolateral Distal Humerus Plate with Lateral Support, 5 Ho

Basic Information

• Brand Name: 2.7/3.5mm Wise-Lock Dorsolateral Distal Humerus Plate with Lateral Support, 5 Ho
• Primary DI: 08903993202890
• Version / Model: 743.105R
• Catalog Number: A3-DND-QF-001-WF3
• Company Name: Auxein Medical Private Limited
• Labeler DUNS: 872194615
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-27
• Public Version: 4
• Public Version Date: 2024-02-19
• Public Version Status: Update
• Public Device Record Key: 9314d093-d4d6-4d74-89a1-de305446bdd3

Device Description

The plates are designed in right and left configurations, as well as various length configurations. The plates are contoured to provide a close fit with the distal humerus

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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
HRS	Plate, Fixation, Bone	Orthopedic	888.3030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46649	Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial	A collection of small sheets of firm material and bone screws intended to be implanted onto fractured bone fragments to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals. The components are made of a material that is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre); it does not include an antimicrobial agent(s). Tools for implantation may be included. The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion).	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08903993202890	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K141680	000