NA

Basic Information

• Brand Name: NA
• Primary DI: 00613994618665
• Version / Model: 628285
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 006261481
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-04-01
• Public Version: 4
• Public Version Date: 2023-07-31
• Public Version Status: Update
• Public Device Record Key: 965723ce-beed-4fef-ac13-e496c8b98790
• Distribution End Date: 2022-05-10

Device Description

STYLET 628285 US DS KNOB ST

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
DRB	STYLET, CATHETER	Cardiovascular	870.1380	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46717	Pacing/defibrillation lead stylet	A sterile wire, intended to be percutaneously inserted into the coronary venous vasculature to aid in the transvenous placement and/or removal of implantable pacemaker/defibrillator leads; it may in addition be intended to extract an indwelling catheter or other foreign object. It is manipulated proximally with a handle, and its working end is typically made of extremely thin stainless steel wire (e.g., 0.4 mm to 0.81 mm in diameter), and may be available in various wire lengths and degrees of rigidity. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20613994618669	GS1	PK	5	Not in Commercial Distribution	2022-05-10
Primary	00613994618665	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K010906	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	0.356	Millimeter
Length	85.0	Centimeter