Seal-Tight

GUDID D6837720012

Disposable AirWater Syringe Tip Delivers Dry Air on Demand Every Time

METREX RESEARCH, LLC

Dental irrigation/aspiration syringe

• Primary Device ID: D6837720012
• NIH Device Record Key: 3f53bc56-3076-41a7-847e-eb137661e545
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Seal-Tight
• Version Model Number: 77200C
• Company DUNS: 145963778
• Company Name: METREX RESEARCH, LLC
• Device Count: 200
• 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	00615375003756 [Primary]
GS1	00615375006849 [Unit of Use]
HIBCC	D6837720012 [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 [Seal-Tight]

• D6837750015: Disposable AirWater Syringe Tip Delivers Dry Air on Demand Every Time
• D6837720012: Disposable AirWater Syringe Tip Delivers Dry Air on Demand Every Time
• D683722001: Spectrum Disposable AirWater Syringe Tips in Assorted Colors that Deliver Dry Air on Demand