FDA.reportPublic FDA data

MONARCH™ Stone Retrieval Basket

Primary DI
10810068811091
Brand
MONARCH™ Stone Retrieval Basket
Company
Auris Health, Inc.
Model
MUR-000015
Catalog number
MUR-000015
Device description
Stone retrieval basket and introducer
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
FFLDislodger, Stone, Basket, Ureteral, Metal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFLDislodger, Stone, Basket, Ureteral, MetalGastroenterology, 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
20810068811098PackageGS11In Commercial Distribution
30810068811095PackageGS15In Commercial Distribution
10810068811091PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081006881109820810068811098
3081006881109530810068811095
1081006881109110810068811091

GMDN Terms#

Term, Definition table
TermDefinition
Urinary stone retrieval basket, single-useA manual endotherapy instrument designed to be inserted through the working channel of an endoscope to trap, retrieve, and/or manipulate urinary stones for the treatment of conditions such as nephrolithiasis and urolithiasis (i.e., presence of calculi in the kidneys or urinary tract). It typically consists of a flexible sheath with a braided self-expanding basket [typically made of nickel-titanium alloy (Nitinol)] at the distal end. A handle located at the proximal end of the instrument is designed to open, close, and rotate the basket. The device is used with a nephroscope or ureteroscope during urological and related procedures. This is a single-use device.

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
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
10810068811107MONARCH™ Urology Irrigation CartridgeMUR-000016MUR-0000162026-05-04
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
B634MON0000060Monarch Bronchscope 2.0/Monarch Platform (P2)MON-0000062020-04-21
B634MON000005R0Monarch™ Platform (Refurbished)MON000005RMON000005R2019-05-10
B634MON0000050Monarch™ PlatformMON000005MON0000052018-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06976358502845SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358502852SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358502869SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358502876SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358502883SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358502890SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358502906SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358502913SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358502920SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358502937SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358502944SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358502951SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358502968SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358502975SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358502982SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358502999SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358503002SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358503019SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358503026SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358503033SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358503040SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358503057SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06973356553886TriousShenzhen Trious Medical Technology Co., Ltd.FFL2026-05-09
06973356554081TriousShenzhen Trious Medical Technology Co., Ltd.FFL2026-05-09
06973356553961TriousShenzhen Trious Medical Technology Co., Ltd.FFL2026-04-22
00810116023721Dornier MedTech DORNIER MEDTECH AMERICA, INC.FFL2026-04-21
00810116023738Dornier MedTech DORNIER MEDTECH AMERICA, INC.FFL2026-04-21
00810116023745Dornier MedTech DORNIER MEDTECH AMERICA, INC.FFL2026-04-21
04953170458361DISPOSABLE GRASPING FORCEPSOLYMPUS MEDICAL SYSTEMS CORP.FFL2025-05-14
04953170458415DISPOSABLE GRASPING FORCEPSOLYMPUS MEDICAL SYSTEMS CORP.FFL2025-05-14