Bagley
GUDID 00821925007833
Bagley Self-Dilating Autoclavable Semi-Rigid Ureteroscope
Gyrus Acmi, Inc.
Rigid optical ureteroscope| Primary Device ID | 00821925007833 |
| NIH Device Record Key | 59272245-92b2-4eaa-a804-413471c92d35 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bagley |
| Version Model Number | REXMR-6LA |
| Company DUNS | 007198742 |
| Company Name | Gyrus Acmi, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Handling Environment Temperature | Between 123 Degrees Fahrenheit and 123 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 123 KiloPascal and 123 KiloPascal |
| Handling Environment Humidity | Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 123 Degrees Fahrenheit and 123 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 123 KiloPascal and 123 KiloPascal |
| Handling Environment Humidity | Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 123 Degrees Fahrenheit and 123 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 123 KiloPascal and 123 KiloPascal |
| Handling Environment Humidity | Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 123 Degrees Fahrenheit and 123 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 123 KiloPascal and 123 KiloPascal |
| Handling Environment Humidity | Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 123 Degrees Fahrenheit and 123 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 123 KiloPascal and 123 KiloPascal |
| Handling Environment Humidity | Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 123 Degrees Fahrenheit and 123 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 123 KiloPascal and 123 KiloPascal |
| Handling Environment Humidity | Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 123 Degrees Fahrenheit and 123 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 123 KiloPascal and 123 KiloPascal |
| Handling Environment Humidity | Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 123 Degrees Fahrenheit and 123 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 123 KiloPascal and 123 KiloPascal |
| Handling Environment Humidity | Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 123 Degrees Fahrenheit and 123 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 123 KiloPascal and 123 KiloPascal |
| Handling Environment Humidity | Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 123 Degrees Fahrenheit and 123 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 123 KiloPascal and 123 KiloPascal |
| Handling Environment Humidity | Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 123 Degrees Fahrenheit and 123 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 123 KiloPascal and 123 KiloPascal |
| Handling Environment Humidity | Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 123 Degrees Fahrenheit and 123 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 123 KiloPascal and 123 KiloPascal |
| Handling Environment Humidity | Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 123 Degrees Fahrenheit and 123 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 123 KiloPascal and 123 KiloPascal |
| Handling Environment Humidity | Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 123 Degrees Fahrenheit and 123 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 123 KiloPascal and 123 KiloPascal |
| Handling Environment Humidity | Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 123 Degrees Fahrenheit and 123 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 123 KiloPascal and 123 KiloPascal |
| Handling Environment Humidity | Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 123 Degrees Fahrenheit and 123 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 123 KiloPascal and 123 KiloPascal |
| Handling Environment Humidity | Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 123 Degrees Fahrenheit and 123 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 123 KiloPascal and 123 KiloPascal |
| Handling Environment Humidity | Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 123 Degrees Fahrenheit and 123 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 123 KiloPascal and 123 KiloPascal |
| Handling Environment Humidity | Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 123 Degrees Fahrenheit and 123 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 123 KiloPascal and 123 KiloPascal |
| Handling Environment Humidity | Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 123 Degrees Fahrenheit and 123 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 123 KiloPascal and 123 KiloPascal |
| Handling Environment Humidity | Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 123 Degrees Fahrenheit and 123 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 123 KiloPascal and 123 KiloPascal |
| Handling Environment Humidity | Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 123 Degrees Fahrenheit and 123 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 123 KiloPascal and 123 KiloPascal |
| Handling Environment Humidity | Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 123 Degrees Fahrenheit and 123 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 123 KiloPascal and 123 KiloPascal |
| Handling Environment Humidity | Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 123 Degrees Fahrenheit and 123 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 123 KiloPascal and 123 KiloPascal |
| Handling Environment Humidity | Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 123 Degrees Fahrenheit and 123 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 123 KiloPascal and 123 KiloPascal |
| Handling Environment Humidity | Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 123 Degrees Fahrenheit and 123 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 123 KiloPascal and 123 KiloPascal |
| Handling Environment Humidity | Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 123 Degrees Fahrenheit and 123 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 123 KiloPascal and 123 KiloPascal |
| Handling Environment Humidity | Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 123 Degrees Fahrenheit and 123 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 123 KiloPascal and 123 KiloPascal |
| Handling Environment Humidity | Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 123 Degrees Fahrenheit and 123 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 123 KiloPascal and 123 KiloPascal |
| Handling Environment Humidity | Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 123 Degrees Fahrenheit and 123 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 123 KiloPascal and 123 KiloPascal |
| Handling Environment Humidity | Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 123 Degrees Fahrenheit and 123 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 123 KiloPascal and 123 KiloPascal |
| Handling Environment Humidity | Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 123 Degrees Fahrenheit and 123 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 123 KiloPascal and 123 KiloPascal |
| Handling Environment Humidity | Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 123 Degrees Fahrenheit and 123 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 123 KiloPascal and 123 KiloPascal |
| Handling Environment Humidity | Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 123 Degrees Fahrenheit and 123 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 123 KiloPascal and 123 KiloPascal |
| Handling Environment Humidity | Between 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00821925007833 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K052044
FDA Product Code
| FGB | Ureteroscope And Accessories, Flexible/Rigid |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-01 |
| Device Publish Date | 2024-07-24 |
Devices Manufactured by Gyrus Acmi, Inc.
| 00821925043916 - SOLTIVE | 2024-08-09 SOLTIVE SuperPulsed Laser Fiber 150 Micron |
| 00821925043930 - SOLTIVE | 2024-08-09 SOLTIVE SuperPulsed Laser Fiber 200 Micron |
| 00821925043978 - SOLTIVE | 2024-08-09 SOLTIVE SuperPulsed Laser Fiber 200 Micron |
| 00821925043992 - SOLTIVE | 2024-08-09 SOLTIVE SuperPulsed Laser Fiber 365 Micron |
| 00821925044074 - SOLTIVE | 2024-08-09 SOLTIVE SuperPulsed Laser Fiber 940 Micron |
| 00821925002074 - USA Elite System | 2024-08-02 USA Elite System Continuous Flow Resectoscope Outer Sheath, Raised Tip 25.6 Fr, (8.5 mm) Color Coded Yellow |
| 00821925002098 - USA Elite System | 2024-08-02 USA Elite System Continuous Flow Resectoscope Outer Sheath, Round Tip 25.6 Fr, (8.5 mm) Color Coded Yellow |
| 00821925002111 - USA Elite System | 2024-08-02 USA Elite System Rotating Continuous Flow Resectoscope Inner Sheath 25.6 Fr, (8.5 mm) Color Coded Gold |
Trademark Results [Bagley]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BAGLEY 88349772 not registered Live/Pending |
Bagley Bait Company LLC 2019-03-21 |
 BAGLEY 76004097 2425325 Dead/Cancelled |
Rogan, Michael P. 2000-03-17 |
 BAGLEY 76004095 2425324 Dead/Cancelled |
Rogan, Michael P. 2000-03-17 |
 BAGLEY 75303387 not registered Dead/Abandoned |
REAL CHARACTERS, INC. 1997-06-04 |
 BAGLEY 73433030 1309523 Live/Registered |
Bagley-Sociedad Anomina 1983-07-01 |
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