FDA.reportPublic FDA data

CoralWell

Primary DI
06975339627607
Brand
CoralWell
Company
MacroLux Medical Technology Co., Ltd.
Model
NS-0935B
Published
2025-08-10
Public version status
Update
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
FEDEndoscopic Access Overtube, Gastroenterology-Urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FEDEndoscopic Access Overtube, Gastroenterology-UrologyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16975339627604PackageGS11In Commercial Distribution
26975339627601PackageGS110In Commercial Distribution
06975339627607PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697533962760416975339627604
2697533962760126975339627601
06975339627607069753396276076975339627607

GMDN Terms#

Term, Definition table
TermDefinition
Ureteral introduction sheathA flexible tube intended to be used for ureteral access to allow introduction of other instruments (e.g., endoscope, catheter) and/or for guidewire exchange during a urological procedure. It may be intended for ureteral access via transurethral and/or percutaneous approach, and typically includes an inner dilator; it is however not a full introduction set. This is a single-use device.

Regulatory Flags#

DUNS number
723490133
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975339620318CoralView®U10-B2024-03-12
06975339620325CoralView®U10-BR2024-03-12
06975339620332CoralView®U202024-03-28
06975339620349CoralView®U20-B2024-03-28
06975339620356CoralView®U20-BR2024-03-28
06975339621179BubbleView®C50-C2024-07-10
06975339621186BubbleView®C50-CR2024-07-10
06975339621193BubbleView®C50-CB2024-07-10
06975339621209BubbleView®C50-CBR2024-07-10
06975339623173SeleneView®HC29-G2024-08-23
06975339623180SeleneView®HC352024-08-23
06975339623197SeleneView®HC35-G2024-08-23
06975339623203SeleneView®HO352024-08-23
06975339623210SeleneView®HO35-G2024-08-23
06975339623227SeleneView®HO422024-08-23
06975339623234SeleneView®HO42-G2024-08-23
06975339627560CoralWellNS-0835B2025-08-10
06975339627577CoralWellNS-0840B2025-08-10
06975339627584CoralWellNS-0845B2025-08-10
06975339627591CoralWellNS-0855B2025-08-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06936345101536Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345101543Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104469Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104476Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104483Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104490Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104544Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104551Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104568Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104575Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06925816667213ClearPetraWell Lead Medical Co.,LtdFED2026-03-16
06925816667220ClearPetraWell Lead Medical Co.,LtdFED2026-03-16
06925816667237ClearPetraWell Lead Medical Co.,LtdFED2026-03-16
06925816657511ClearPetraWell Lead Medical Co.,LtdFED2026-01-26
06925816657528ClearPetraWell Lead Medical Co.,LtdFED2026-01-26
06925816657535ClearPetraWell Lead Medical Co.,LtdFED2026-01-26
06925816657542ClearPetraWell Lead Medical Co.,LtdFED2026-01-26
06925816657559ClearPetraWell Lead Medical Co.,LtdFED2026-01-26
06925816657566ClearPetraWell Lead Medical Co.,LtdFED2026-01-26
06925816657573ClearPetraWell Lead Medical Co.,LtdFED2026-01-26
06925816657580ClearPetraWell Lead Medical Co.,LtdFED2026-01-26
06925816657597ClearPetraWell Lead Medical Co.,LtdFED2026-01-26
06925816657603ClearPetraWell Lead Medical Co.,LtdFED2026-01-26
06925816657610ClearPetraWell Lead Medical Co.,LtdFED2026-01-26
06925816657627ClearPetraWell Lead Medical Co.,LtdFED2026-01-26
06925816657634ClearPetraWell Lead Medical Co.,LtdFED2026-01-26
06925816657641ClearPetraWell Lead Medical Co.,LtdFED2026-01-26
06925816657658ClearPetraWell Lead Medical Co.,LtdFED2026-01-26
06925816657665ClearPetraWell Lead Medical Co.,LtdFED2026-01-26
06925816657672ClearPetraWell Lead Medical Co.,LtdFED2026-01-26