Galaxy System
GUDID 00000850048825
The Galaxy System is designed with the intent to enable articulation and precise control of a flexible, single-use disposable bronchoscope under continuous and direct control by a physician operator. The Galaxy System™ includes full procedure navigation that integrates a pre-operative computed tomography scan to display scope tip location relative to the pre-operative scan anatomy. Additionally, Galaxy integrates a tomosynthesis spin to update the scope and target position to overcome any changes in anatomy not reflected in the pre-op CT scan.
Noah Medical Corporation
Flexible video bronchoscope, reusable| Primary Device ID | 00000850048825 |
| NIH Device Record Key | 23caa8bf-bd1b-410f-9912-93671dc719a9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Galaxy System |
| Version Model Number | GAL-001 |
| Company DUNS | 117566482 |
| Company Name | Noah Medical Corporation |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 650-670-6972 |
| sammostafavi@noahmed.com | |
| Phone | 650-670-6972 |
| sammostafavi@noahmed.com | |
| Phone | 650-670-6972 |
| sammostafavi@noahmed.com | |
| Phone | 650-670-6972 |
| sammostafavi@noahmed.com | |
| Phone | 650-670-6972 |
| sammostafavi@noahmed.com | |
| Phone | 650-670-6972 |
| sammostafavi@noahmed.com | |
| Phone | 650-670-6972 |
| sammostafavi@noahmed.com | |
| Phone | 650-670-6972 |
| sammostafavi@noahmed.com | |
| Phone | 650-670-6972 |
| sammostafavi@noahmed.com | |
| Phone | 650-670-6972 |
| sammostafavi@noahmed.com | |
| Phone | 650-670-6972 |
| sammostafavi@noahmed.com | |
| Phone | 650-670-6972 |
| sammostafavi@noahmed.com | |
| Phone | 650-670-6972 |
| sammostafavi@noahmed.com | |
| Phone | 650-670-6972 |
| sammostafavi@noahmed.com | |
| Phone | 650-670-6972 |
| sammostafavi@noahmed.com | |
| Phone | 650-670-6972 |
| sammostafavi@noahmed.com | |
| Phone | 650-670-6972 |
| sammostafavi@noahmed.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00000850048825 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K223144
FDA Product Code
| EOQ | Bronchoscope (Flexible Or Rigid) |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00000850048825]
Ethylene Oxide
[00000850048825]
Ethylene Oxide
[00000850048825]
Ethylene Oxide
[00000850048825]
Ethylene Oxide
[00000850048825]
Ethylene Oxide
[00000850048825]
Ethylene Oxide
[00000850048825]
Ethylene Oxide
[00000850048825]
Ethylene Oxide
[00000850048825]
Ethylene Oxide
[00000850048825]
Ethylene Oxide
[00000850048825]
Ethylene Oxide
[00000850048825]
Ethylene Oxide
[00000850048825]
Ethylene Oxide
[00000850048825]
Ethylene Oxide
[00000850048825]
Ethylene Oxide
[00000850048825]
Ethylene Oxide
[00000850048825]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-19 |
| Device Publish Date | 2024-11-11 |
Devices Manufactured by Noah Medical Corporation
| 00850048825055 - Accessory Kit | 2024-12-23 Galaxy system accessory kit |
| 00850048825062 - Basic Accessory Kit | 2024-12-23 Galaxy system basic accessory kit |
| 00850048825000 - Bronchoscope | 2024-12-19 The Galaxy System and bronchoscopic is intended to provide visualization of patient airways for diagnostic procedures. |
| 00850048825017 - Bronchoscope connector | 2024-12-19 Bronchoscope connector |
| 00850048825031 - Bronchoscope guide | 2024-12-19 Scope guide |
| 00000850048825 - Galaxy System | 2024-11-19The Galaxy System is designed with the intent to enable articulation and precise control of a flexible, single-use disposable bronchoscope under continuous and direct control by a physician operator. The Galaxy System™ includes full procedure navigation that integrates a pre-operative computed tomography scan to display scope tip location relative to the pre-operative scan anatomy. Additionally, Galaxy integrates a tomosynthesis spin to update the scope and target position to overcome any changes in anatomy not reflected in the pre-op CT scan. |
| 00000850048825 - Galaxy System | 2024-11-19 The Galaxy System is designed with the intent to enable articulation and precise control of a flexible, single-use disposable br |
Trademark Results [Galaxy System]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GALAXY SYSTEM 97101945 not registered Live/Pending |
Noah Medical Corporation 2021-11-01 |
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