Home GUDID 10860011958328 esolution Esophageal Retractor PRECISION
Primary DI 10860011958328
Brand esolution Esophageal Retractor PRECISION
Company S4 Medical Corp.
Model 30-0003
Catalog number 30-0003
Device description Mechanical Deviation Device for Esophageal Protection during Cardiac Ablation Procedures
Published 2026-01-05
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name QXU Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QXU Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10860011958328 Package GS1 5 In Commercial Distribution 00860011958321 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10860011958328 10860011958328 00860011958321 00860011958321 860011958321 0860011958321
GMDN Terms# Term, Definition table Term Definition 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.
Regulatory Flags# DUNS number 081128564 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00860011958314 esolution Esophageal Retractor PRECISION - temp 30-0002 30-0002 2026-01-05 00860011958321 esolution Esophageal Retractor PRECISION 30-0003 30-0003 2026-01-05 00860011958307 esolution Esophageal Retractor 30-0001 30-0001 2026-01-05 10860011958311 esolution Esophageal Retractor PRECISION - temp 30-0002 30-0002 2026-01-05
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00860011958314 esolution Esophageal Retractor PRECISION - temp S4 Medical Corp. QXU 2026-01-05 00860011958321 esolution Esophageal Retractor PRECISION S4 Medical Corp. QXU 2026-01-05 00860011958307 esolution Esophageal Retractor S4 Medical Corp. QXU 2026-01-05 10860011958311 esolution Esophageal Retractor PRECISION - temp S4 Medical Corp. QXU 2026-01-05