FDA.reportPublic FDA data

Halo Trinity

Primary DI
B0325561300
Brand
Halo Trinity
Company
SACRED HEART MEDICAL,INC.
Model
556130
Catalog number
556130
Device description
1.5 Fr, 120 cm, NiTi Tipless Stone Basket
Published
2022-12-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B0325561300PrimaryHIBCC0

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
832763002
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
B0323425150Summit3425153425152016-11-15
B032500240Biliary Stone Basket50024500242017-05-26
B0325503100Vantage5503105503102016-11-15
B0325550200Halo5550205550202024-07-18
B0325305200Hercules5305205305202016-11-15
B0325305250Hercules5305255305252016-11-15
B0325443100Apex5443105443102016-11-15
B0325443200Apex5443205443202016-11-15
B0325503200Vantage5503205503202016-11-15
B0325541200Halo5541205541202016-11-15
B03255616006-Wire Halo5561605561602016-11-15

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
10810068811091MONARCH™ Stone Retrieval BasketAuris Health, Inc.FFL2026-05-04
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