MedSource Stylet, Individually Packaged, 12FR

Basic Information

• Brand Name: MedSource Stylet, Individually Packaged, 12FR
• Primary DI: 00816703020463
• Version / Model: MS-ETS300
• Company Name: MEDSOURCE INTERNATIONAL LLC
• Labeler DUNS: 041674552
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-22
• Public Version: 3
• Public Version Date: 2022-12-20
• Public Version Status: Update
• Public Device Record Key: cd4d614d-528b-4b4c-bfc6-5a4f37dc83f8

Device Description

Stylet, Individually Packaged, 12FR

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: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	868.5730	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37469	Artificial airway stylet, single-use	A long stiffening wire/rod designed for insertion within the lumen of an artificial airway tube (e.g., endotracheal tube, bronchial tube) to stiffen and/or maintain the shape of the tube to facilitate introduction (intubation). It is designed to be slightly shorter than the tube to avoid damage to the airway during passage, and is withdrawn after intubation has been completed. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816703020463	GS1