Safe-Tips EZ

GUDID D6834415010

Disposable AirWater Syringe Tip Interchangeable with Most Metal Tips

METREX RESEARCH, LLC

Dental irrigation/aspiration syringe

• Primary Device ID: D6834415010
• NIH Device Record Key: 763a3b66-3421-4105-a1d3-bd8fb9bc420d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Safe-Tips EZ
• Version Model Number: 44150C
• Company DUNS: 145963778
• Company Name: METREX RESEARCH, LLC
• Device Count: 150
• 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: 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: +18008411428
• Email: customercare@kavokerrgroup.com
• Phone: +18008411428
• Email: customercare@kavokerrgroup.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00615375003695 [Primary]
GS1	00615375006788 [Unit of Use]
HIBCC	D6834415010 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K951238

FDA Product Code

• EIA: UNIT, OPERATIVE DENTAL

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: 2016-08-31

On-Brand Devices [Safe-Tips EZ]

• D6834460010: Disposable AirWater Syringe Tip Interchangeable with Most Metal Tips
• D6834415010: Disposable AirWater Syringe Tip Interchangeable with Most Metal Tips