Hu-Friedy UI25SD10

GUDID 10889950075361

10 Swivel Direct Flow, 25K

HU-FRIEDY MFG. CO., LLC

Ultrasonic dental scaling/debridement system handpiece tip, periodontal

• Primary Device ID: 10889950075361
• NIH Device Record Key: de07b4ab-94d0-42a0-8e33-b5161a063a12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hu-Friedy
• Version Model Number: UI25SD10
• Catalog Number: UI25SD10
• 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: true
• Serial Number: false
• 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
• Email: info@hu-friedy.com
• Phone: +1(800)483-7433
• Email: info@hu-friedy.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889950075361 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012060

FDA Product Code

• ELC: Scaler, ultrasonic

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[10889950075361]

Moist Heat or Steam Sterilization

[10889950075361]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-05-30

On-Brand Devices [Hu-Friedy]

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• 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