S 45-K

Basic Information

• Brand Name: S 45-K
• Primary DI: 04035479144968
• Version / Model: 113588
• Catalog Number: 113588
• Company Name: BIOTRONIK SE & Co. KG
• Labeler DUNS: 315620229
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-08-14
• Public Version: 5
• Public Version Date: 2023-10-06
• Public Version Status: Update
• Public Device Record Key: bc353c44-e005-4156-bbce-b04258f416ad

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: Yes
• 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
62919	Vascular catheter stylet	A thin sterile wire intended to be inserted within the lumen of a vascular catheter [e.g., peripheraly inserted venous catheter (PICC)] to stiffen and/or maintain the shape of the catheter to facilitate insertion; it is not intended for introduction into the coronary vasculature. It may be magnetic to enable use with a magnetic tracking system. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	04035479002022	GS1	case	10	In Commercial Distribution
Primary	04035479144968	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K191469	000
P950037	034

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 41 – 131 Degrees Fahrenheit