NA

Basic Information

• Brand Name: NA
• Primary DI: 00643169887428
• Version / Model: 3550-02
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 796986144
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-10-20
• Public Version: 4
• Public Version Date: 2023-01-13
• Public Version Status: Update
• Public Device Record Key: 460f7330-6c9b-41d6-ab87-93986cee12e1
• Distribution End Date: 2023-01-02

Device Description

ACCY KIT 3550-02 WRENCH/SCREWS US FWU

Device Characteristics

• Single Use: Yes
• 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: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GZF	STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF)	Neurology	882.5870	2
GZB	STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)	Neurology	882.5880	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44063	Neurosurgical procedure kit, non-medicated, single-use	A collection of various sterile neurosurgical instruments, dressings and the necessary materials used to perform a neurosurgical procedure. It does not contain pharmaceuticals. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00643169887428	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K960631	000