Stylet

Basic Information

• Brand Name: Stylet
• Primary DI: 00607915111199
• Version / Model: A4S140
• Company Name: APPLIED MEDICAL RESOURCES CORPORATION
• Labeler DUNS: 187129135
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-19
• Public Version: 3
• Public Version Date: 2019-02-08
• Public Version Status: Update
• Public Device Record Key: f508bcc2-bb9e-41a0-ace3-6b7b8d7bddaa
• Distribution End Date: 2018-07-09

Device Description

Catheter Stylet

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
DXE	Catheter, Embolectomy	Cardiovascular	870.5150	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	10607915111196	GS1		10	Not in Commercial Distribution	2018-07-09
Primary	00607915111199	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	40	Centimeter
Device Size Text, specify			0.010 Inch Dia