FDA.reportPublic FDA data

JOSEPH LAMELAS Intercostal Retractor System Medium Blade Set

Primary DI
08022057015792
Brand
JOSEPH LAMELAS Intercostal Retractor System Medium Blade Set
Company
CORCYM SRL
Model
MI-IRS-MB-P01
Catalog number
MI-IRS-MB-P01
Device description
The Joseph Lamelas Intercostal Retractor System product is a reusable thoracotomy retractor system. The individual accessory components include a retractor rack, 4 different sized paired blade set options, 2 different sized double swivel blade options and a custom sterilization tray
Published
2026-02-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DWSInstruments, Surgical, Cardiovascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08022057015792PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08022057015792080220570157928022057015792

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retractor/retraction system blade, reusableA distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge to separate the margins of a wound/incision during a surgical procedure. It is intended to be attached to the frame (e.g., mounting ring/bar) of a surgical retraction system, or may be fixed onto a retractor handle; it does not include a handle. It is a metal device, sometimes referred to as a variable or vario retractor blade when assembled with a separate retractor handle, because it is available in a variety of lengths and sizes. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
441454802
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08022057015952Memo 4D Curve4DC244DC242026-07-04
08022057015969Memo 4D Curve4DC264DC262026-07-04
08022057015976Memo 4D Curve4DC284DC282026-07-04
08022057015983Memo 4D Curve4DC304DC302026-07-04
08022057015990Memo 4D Curve4DC324DC322026-07-04
08022057016003Memo 4D Curve4DC344DC342026-07-04
08022057016010Memo 4D Curve4DC364DC362026-07-04
08022057016027Memo 4D Curve4DC384DC382026-07-04
08022057016034Memo 4D Curve4DC404DC402026-07-04
08022057016041Memo 4D Curve4DC424DC422026-07-04
08022057015747JOSEPH LAMELAS Atrial Lift SystemMI-ALS-001MI-ALS-0012026-02-03
08022057015754CUFF Aortic Root Exposure DeviceMI-CUFF-001MI-CUFF-0012026-02-03
08022057015853SUTURE BELT Circumferential Suture OrganizerMI-ISBA-001MI-ISBA-0012026-02-03
08022057015860TIE Intracorporeal Knot Placement Assist and COLLAR Papillary Muscle ExposureMI-COTIE-001MI-COTIE-0012026-02-03
08022057015877JOSEPH LAMELAS Knot PusherMI-KP-001MI-KP-0012026-02-03
08022057015884DeTACH Aortic Cross Clamp Head-LargeMI-XCHL-851MI-XCHL-8512026-02-03
08022057015907DeTACH Aortic Cross Clamp Head-SmallMI-XCHS-551MI-XCHS-5512026-02-03
18022057015744JOSEPH LAMELAS Atrial Lift SystemMI-ALS-001MI-ALS-0012026-02-03
18022057015751CUFF Aortic Root Exposure DeviceMI-CUFF-001MI-CUFF-0012026-02-03
08022057015761JOSEPH LAMELAS Intercostal Retractor System KitMI-IRS-222MI-IRS-2222026-02-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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