esolution Esophageal Retractor

Basic Information

• Brand Name: esolution Esophageal Retractor
• Primary DI: 00860011958307
• Version / Model: 30-0001
• Catalog Number: 30-0001
• Company Name: S4 Medical Corp.
• Labeler DUNS: 081128564
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-01-05
• Public Version: 1
• Public Version Date: 2026-01-13
• Public Version Status: New
• Public Device Record Key: 86b01cee-fb24-490a-b967-b484eba3b2f4

Device Description

Mechanical Deviation Device for Esophageal Protection during Cardiac Ablation Procedures

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 Unsafe
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QXU	Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation	Cardiovascular	870.5710	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62204	Intraluminal oesophageal retractor	A hand-held manual instrument intended to be orally introduced into the oesophagus during thoracic surgery to mechanically divert the oesophagus away from the site of surgery, to facilitate surgical site access and to help prevent injury. It is available in a variety of forms (e.g., curved metal wire, metal rod with balloon). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860011958307	GS1
Package	10860011958304	GS1	Box	5	In Commercial Distribution