FDA.reportPublic FDA data

esolution Esophageal Retractor PRECISION - temp

Primary DI
00860011958314
Brand
esolution Esophageal Retractor PRECISION - temp
Company
S4 Medical Corp.
Model
30-0002
Catalog number
30-0002
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
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
QXUEsophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QXUEsophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical DeviationCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860011958311PackageGS15In Commercial Distribution
00860011958314PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086001195831110860011958311
00860011958314008600119583148600119583140860011958314

GMDN Terms#

Term, Definition table
TermDefinition
Intraluminal oesophageal retractorA 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
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860011958321esolution Esophageal Retractor PRECISION30-000330-00032026-01-05
00860011958307esolution Esophageal Retractor30-000130-00012026-01-05
10860011958311esolution Esophageal Retractor PRECISION - temp30-000230-00022026-01-05
10860011958328esolution Esophageal Retractor PRECISION30-000330-00032026-01-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860011958321esolution Esophageal Retractor PRECISIONS4 Medical Corp.QXU2026-01-05
00860011958307esolution Esophageal RetractorS4 Medical Corp.QXU2026-01-05
10860011958311esolution Esophageal Retractor PRECISION - tempS4 Medical Corp.QXU2026-01-05
10860011958328esolution Esophageal Retractor PRECISIONS4 Medical Corp.QXU2026-01-05