Abutment replica for Vistafix VXA300

Basic Information

• Brand Name: Abutment replica for Vistafix VXA300
• Primary DI: 09321502063418
• Version / Model: 93185
• Company Name: Cochlear Bone Anchored Solutions AB
• Labeler DUNS: 559784736
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-11
• Public Version: 1
• Public Version Date: 2023-08-21
• Public Version Status: New
• Public Device Record Key: d1298c46-6b69-4e40-b0a0-9657421535a6

Device Description

to be used together with the Impression coping and Guide pins to get the exact position of the actual abutments when making a cast of the prosthesis site

Device Characteristics

• Single Use: No
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FZE	PROSTHESIS, NOSE, INTERNAL	General, Plastic Surgery	878.3680	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44758	General external orthopaedic fixation system implantation kit, reusable	A collection of mostly instruments intended to be used to manipulate and prepare soft-tissue and bone for the adjustment or placement of the implantable components of an external orthopaedic fixation system in various skeletal areas (e.g., bones of limbs, spine, pelvis, craniomaxillofacial areas). It is a non-dedicated device that includes various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, cutters, screwdrivers, guides, tighteners) that are specific to the fixation system applied; the implant(s) is not included. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09321502063418	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K945154	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at room temperature