Capture High Torque Screw System

Basic Information

• Brand Name: Capture High Torque Screw System
• Primary DI: 00885556822562
• Version / Model: AI-3205
• Catalog Number: AI-3205
• Company Name: Smith & Nephew, Inc.
• Labeler DUNS: 045483575
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-21
• Public Version: 2
• Public Version Date: 2023-09-07
• Public Version Status: Update
• Public Device Record Key: 43f58a83-98b9-4d73-b1db-81f9023b1a42

Device Description

CANNULA CLEANING STYLET 1.6MM DIA.

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
LXH	Orthopedic manual surgical instrument	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35589	Intramedullary canal cleaning brush, reusable	A hand-held manual surgical instrument designed to remove blood clots and bone debris from the intramedullary canal of a bone (marrow space) in preparation for the insertion of orthopaedic cement. It typically consists of a handle at the proximal end and bristles, fibres, or spines at the distal end which may be soft or stiff and are mounted along a single plane or radiate out around a central shaft which may be flexible or rigid. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00885556822562	GS1

Customer Contacts

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