| Primary Device ID | B0325541200 | 
| NIH Device Record Key | 0d262d7f-8aaf-403c-bd46-d81a18f1d160 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Halo | 
| Version Model Number | 554120 | 
| Catalog Number | 554120 | 
| Company DUNS | 832763002 | 
| Company Name | SACRED HEART MEDICAL,INC. | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | true | 
| MRI Safety Status | Labeling does not contain MRI Safety Information | 
| Human Cell/Tissue Product | false | 
| Device Kit | false | 
| Device Combination Product | false | 
| Single Use | true | 
| Lot Batch | true | 
| Serial Number | false | 
| Manufacturing Date | false | 
| Expiration Date | true | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | false | 
| OTC Over-The-Counter | false | 
| Device Issuing Agency | Device ID | 
|---|---|
| HIBCC | B0325541200 [Primary] | 
| FFL | Dislodger, Stone, Basket, Ureteral, Metal | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 2 | 
| Public Version Date | 2018-03-29 | 
| Device Publish Date | 2016-11-15 | 
| B0325541200 | 1.5 Fr, 120 cm, NiTi Tipless Stone Basket | 
| B0325550200 | 1.3 Fr, 120 cm, NiTi Tipless Stone Basket | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  HALO  98784300  not registered Live/Pending | Skin Safeguard Inc. 2024-10-03 | 
|  HALO  98767255  not registered Live/Pending | Protect Animals With Satellites, LLC 2024-09-24 | 
|  HALO  98765686  not registered Live/Pending | Powered by Halo Inc. 2024-09-23 | 
|  HALO  98691381  not registered Live/Pending | OASIS CONSUMER HEALTHCARE LLC. 2024-08-09 | 
|  HALO  98685312  not registered Live/Pending | ECD Lacrosse, Inc. 2024-08-06 | 
|  HALO  98678393  not registered Live/Pending | Metsera, Inc. 2024-08-01 | 
|  HALO  98636398  not registered Live/Pending | Seats Incorporated 2024-07-08 | 
|  HALO  98624804  not registered Live/Pending | Samtec Inc. 2024-06-28 | 
|  HALO  98550340  not registered Live/Pending | SYDUCT DIAGNOSTICS INC. 2024-05-14 | 
|  HALO  98529116  not registered Live/Pending | WH Products, LLC 2024-05-01 | 
|  HALO  98473348  not registered Live/Pending | Ultradent Products, Inc. 2024-03-28 | 
|  HALO  98454522  not registered Live/Pending | Halo, Inc. 2024-03-18 |