Hu-Friedy UM3-25UK
GUDID 10889950075842
Magnetostrict.Generator 3000-25k,230V UK
HU-FRIEDY MFG. CO., LLC
Ultrasonic dental scaling/debridement system generator| Primary Device ID | 10889950075842 |
| NIH Device Record Key | 9762d99f-7cff-4cb9-b5ea-2103aea13882 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hu-Friedy |
| Version Model Number | UM3-25UK |
| Catalog Number | UM3-25UK |
| Company DUNS | 005085972 |
| Company Name | HU-FRIEDY MFG. CO., LLC |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| 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 |
Customer Support Contacts
| Phone | +1(800)483-7433 |
| info@hu-friedy.com | |
| Phone | +1(800)483-7433 |
| info@hu-friedy.com | |
| Phone | +1(800)483-7433 |
| info@hu-friedy.com | |
| Phone | +1(800)483-7433 |
| info@hu-friedy.com | |
| Phone | +1(800)483-7433 |
| info@hu-friedy.com | |
| Phone | +1(800)483-7433 |
| info@hu-friedy.com | |
| Phone | +1(800)483-7433 |
| info@hu-friedy.com | |
| Phone | +1(800)483-7433 |
| info@hu-friedy.com | |
| Phone | +1(800)483-7433 |
| info@hu-friedy.com | |
| Phone | +1(800)483-7433 |
| info@hu-friedy.com | |
| Phone | +1(800)483-7433 |
| info@hu-friedy.com | |
| Phone | +1(800)483-7433 |
| info@hu-friedy.com | |
| Phone | +1(800)483-7433 |
| info@hu-friedy.com | |
| Phone | +1(800)483-7433 |
| info@hu-friedy.com | |
| Phone | +1(800)483-7433 |
| info@hu-friedy.com | |
| Phone | +1(800)483-7433 |
| info@hu-friedy.com | |
| Phone | +1(800)483-7433 |
| info@hu-friedy.com |
Operating and Storage Conditions
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10889950075842 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K100401
FDA Product Code
| ELC | Scaler, ultrasonic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-21 |
On-Brand Devices [Hu-Friedy]
| 10889950104252 | 2.2ml Syringe Metric & Imperial Thread |
| 10889950104245 | 1.8ml syringe Metric & Imperial Thread |
| 10889950075903 | Swerv 3 30K Handpiece |
| 10889950075897 | Swerv 3 25K Handpiece |
| 10889950075880 | Magnetostrictive Foot Control, On-Off |
| 10889950075873 | Magnetostrict. Generat 3000-30k,230V UK |
| 10889950075866 | Magnetostrictive Generator 3000-30k,230V |
| 10889950075859 | Magnetostrictive Generator 3000-30k,120V |
| 10889950075842 | Magnetostrict.Generator 3000-25k,230V UK |
| 10889950075835 | Magnetostrict.Generator 3000-25k,230V EU |
| 10889950075828 | Magnetostrictive Generator 3000-25k,120v |
| 10889950075811 | #3 Beavertail Streamline, 30kHz |
| 10889950075804 | #3 Beavertail Streamline, 25kHz |
| 10889950075798 | Swivel XT, 30k |
| 10889950075781 | 1000 Triple SWIVEL, 30k |
| 10889950075774 | 100 Thin SWIVEL, 30k |
| 10889950075767 | 10 Universal SWIVEL, 30k |
| 10889950075750 | XT Triple Bend Streamline DF 30K |
| 10889950075743 | Streamline Direct Flow,30K |
| 10889950075736 | Straight Streamline Direct Flow,30K |
| 10889950075729 | Right Streamline Direct Flow,30K |
| 10889950075712 | Left Streamline Direct Flow,30K |
| 10889950075705 | 1000 Triple Streamline Direct Flow,30K |
| 10889950075699 | 100 Thin Streamline Direct Flow,30K |
| 10889950075682 | 10 Universal Streamline Direct Flow,30K |
| 10889950075675 | XT Triple Bend Swivel Direct Flow 30K |
| 10889950075668 | AF Swivel Direct Flow Stra 30K |
| 10889950075651 | AF Swivel Direct Flow Right30K |
| 10889950075644 | AF Swivel Direct Flow Left 30K |
| 10889950075637 | 1000 Triple Bend Swivel Direct Flow 30k |
| 10889950075620 | 100 Thin Swivel Direct Flow, 30k |
| 10889950075613 | 10 Swivel Direct Flow 30k |
| 10889950075606 | After Five - Straight, 30kHz |
| 10889950075590 | After Five - Right, 30kHz |
| 10889950075583 | After Five - Left, 30kHz |
| 10889950075576 | After Five PLUS - Straight, 30kHz |
| 10889950075569 | After Five PLUS - Right, 30kHz |
| 10889950075552 | After Five PLUS - Left, 30kHz |
| 10889950075545 | #10 Prophy PLUS, 30kHz |
| 10889950075538 | #10 Original Prophy Style, 30kHz |
| 10889950075521 | #100 Thin Universal Streamline,30kHz |
| 10889950075514 | Swivel XT, 25k |
| 10889950075507 | 1000 Triple SATIN SWIVEL, 25k |
| 10889950075491 | 100 Thin SWIVEL, 25k |
| 10889950075484 | 10 Universal SWIVEL, 25k |
| 10889950075477 | Straight Streamline Direct Flow,25K |
| 10889950075460 | Right Streamline Direct Flow,25K |
| 10889950075453 | Left Streamline Direct Flow,25K |
| 10889950075446 | 1000 Triple Streamline Direct Flow,25K |
| 10889950075439 | 100 Thin Streamline Direct Flow,25K |
Trademark Results [Hu-Friedy]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HU-FRIEDY 78837043 3229368 Live/Registered |
HU-FRIEDY MFG. CO., LLC 2006-03-14 |
 HU-FRIEDY 73312072 1220727 Dead/Cancelled |
Hu Friedy Mfg. Co., Inc. 1981-05-26 |
 HU-FRIEDY 73312071 1220726 Live/Registered |
Hu Friedy Mfg. Co., Inc. 1981-05-26 |
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