| Primary Device ID | B0325550200 |
| NIH Device Record Key | e27490b0-986d-4aeb-8210-afc2fda328ba |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Halo |
| Version Model Number | 555020 |
| Catalog Number | 555020 |
| 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 | B0325550200 [Primary] |
| FFL | Dislodger, Stone, Basket, Ureteral, Metal |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-07-26 |
| Device Publish Date | 2024-07-18 |
| 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 |