NA

Basic Information

• Brand Name: NA
• Primary DI: 34546540756504
• Version / Model: 234-030-027
• Catalog Number: 234-030-027
• Company Name: STRYKER CORPORATION
• Labeler DUNS: 187502109
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2015-09-09
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 2e4c8da1-3caf-464e-afc3-a27abb880ee3

Device Description

1.0MM X 14IN NITINOL GUIDE WIRE

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: Yes
• 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
NBH	ACCESSORIES,ARTHROSCOPIC	Orthopedic	888.1100	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58148	Orthopaedic implantation sleeve, single-use	A sterile, hand-held surgical tubular device designed to be used during an orthopaedic implantation procedure to hold/grip an implant (e.g., an orthopaedic bone screw) and/or facilitate the acceptance of an orthopaedic instrument (e.g., a screwdriver or a smaller diameter sleeve) through it, to stabilize an instrument/implant coupling, and/or to protect the surgeon's gloved hand or patient tissue. It is not primarily intended to place, angle, and guide a rotating surgical drill. It is typically made of high-grade stainless steel and/or synthetic materials and is available in various sizes and lengths. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	34546540756504	GS1
Unit of Use	04546540756503	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Diameter: 1.0 Millimeter
Length	14.0	Inch