FDA.reportPublic FDA data

SUTURE BELT Circumferential Suture Organizer

Primary DI
08022057015853
Brand
SUTURE BELT Circumferential Suture Organizer
Company
CORCYM SRL
Model
MI-ISBA-001
Catalog number
MI-ISBA-001
Device description
The Suture Belt device is a circumferential surgical suture organizer that mounts to a retractor rack prior to use. The device incorporates a rigid base frame with 24 flexible holding plug inserts that receive and retain suture pairs. Suture retention is achieved by pressing the suture strands into the compression slots found between the rigid base frame and flexible holding plug inserts. The rigid base frame consists of 2 hinged halves which allow for angle adjustment of the individual segments. The attachment arms allow the device to be mounted to the retractor arms. Two spacer components allow the attachment arm height to be adjusted. The device is secured into the desired orientation and segment angle positioning by tightening the immobilizing thumb screws.
Published
2026-02-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
18022057015850PackageGS16In Commercial Distribution
08022057015853PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1802205701585018022057015850
08022057015853080220570158538022057015853

GMDN Terms#

Term, Definition table
TermDefinition
Operative-site suture holderA device designed to hold suture threads to facilitate their manipulation, positioning and differentiation around the operative site during a surgical procedure. It typically has a circular, oval, or curved shape with grooves or other connecting elements, and is stabilized by attachment to a surgical drape; it may also be attached to an invasive surgical retractor. This is a single-use device.

Regulatory Flags#

DUNS number
441454802
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
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
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
08022057015778JOSEPH LAMELAS Intercostal Retractor System Retractor RackMI-IRS-R-001MI-IRS-R-0012026-02-03

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Primary DI, Brand, Company table
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