N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00885556643266
• Version / Model: 71935023
• Catalog Number: 71935023
• Company Name: Smith & Nephew, Inc.
• Labeler DUNS: 045483575
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-17
• Public Version: 3
• Public Version Date: 2023-09-07
• Public Version Status: Update
• Public Device Record Key: e35059a2-0733-4a39-8c02-fae93b694419

Device Description

STYLET FOR STITCHER

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
13836	Needle stylet	A device made of a thin wire or thin flexible rod that is intended to be inserted into the lumen of a needle to render it stiff and maintain the shape or patency of the needle, or to clear the lumen of the needle. It is available in various wire lengths and diameters, and will typically have a plastic knob at the proximal end. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00885556643266	GS1

Customer Contacts

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