FDA.reportPublic FDA data

MONARCH™ Urology Irrigation Cartridge

Primary DI
10810068811107
Brand
MONARCH™ Urology Irrigation Cartridge
Company
Auris Health, Inc.
Model
MUR-000016
Catalog number
MUR-000016
Device description
Irrigation cartridge and tubing
Published
2026-05-04
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
FGBUreteroscope And Accessories, Flexible/Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGBUreteroscope And Accessories, Flexible/RigidGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213334000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213334000Monarch Platform, UrologyAuris Health, Inc.2022-04-29FGB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20810068811104PackageGS15In Commercial Distribution
30810068811101PackageGS15In Commercial Distribution
10810068811107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081006881110420810068811104
3081006881110130810068811101
1081006881110710810068811107

GMDN Terms#

Term, Definition table
TermDefinition
Urological irrigation systemAn assembly of devices intended for the infusion of sterile fluids (e.g., saline, water) into the ureter and upper urinary tract to irrigate these passageways in a controlled manner during a diagnostic and /or a therapeutic urological procedure; including a urinary tract endoscopic procedure. It typically consists of a mains electricity (AC-powered) pump, tubing, connectors and other items that enable the pressure, temperature, or flow of water to be controlled.

Regulatory Flags#

DUNS number
015823456
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810068810940MONARCH™ Advanced Imaging Accessory KitMON-000709MON-0007092026-06-02
10810068810841MONARCH™ Navigation SensorsMON-000705MON-0007052026-05-27
10810068810858MONARCH™ ControllerMON-000706MON-0007062026-05-27
10810068811046MONARCH™Platform, UrologyMON-000007MON-0000072026-05-05
10810068811053Monarch® Ureteroscopy KitMUR-000011MUR-0000112026-05-05
10810068811077Monarch®Platform Drape KitMUR-000013MUR-0000132026-05-05
10810068811084MONARCH™ Kit Catheter & AccessoriesMUR-000014MUR-0000142026-05-05
10810068811114MONARCH™ Mini-PCNL Suction SetMUR-000017MUR-0000172026-05-05
10810068811060MONARCH™Guided Percutaneous Access KitMUR-000012MUR-0000122026-05-04
10810068811091MONARCH™ Stone Retrieval BasketMUR-000015MUR-0000152026-05-04
10810068811121MONARCH™ Ureteroscope ValveMUR-000026MUR-0000262026-05-04
10810068811138MONARCH™ BronchoscopeMBR-000211-BMBR-000211-B2026-04-21
10810068810896Monarch Bronchscope 2.0/Monarch Platform (P2), RefurbishedMON-000006-RFB2025-08-04
10810068810988Monarch Platform, Bronchoscopy 4.1MON-0000082025-03-03
10810068811169Monarch Platform, Bronchoscopy 4.1, RefurbishedMON-000008-RFB2025-08-04
B634MON0007090Monarch Advanced Imaging Accessory KitMON-000709MON-0007092021-07-15
10810068810803Monarch Bronchscope 2.0/Monarch Platform (P2)MON-0000062024-05-05
B634MON00000501R0Monarch Endoscopy Platform (P1) System, RefurbishedMON-000005-01R2020-03-25
B634MON000005010 Monarch Endoscopy Platform (P1) Tower UpgradeMON-000005-012020-07-13
B634MON00000501 Monarch Endoscopy Platform (P1) Tower UpgradeMON-000005-012020-03-25

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Primary DI, Brand, Company table
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