DentaPure Water Purification Municipal Cartridge

GUDID 00732224005515

Water Purification Municipal Cartridge

CROSSTEX INTERNATIONAL, INC.

Dental waterline disinfectant cartridge

• Primary Device ID: 00732224005515
• NIH Device Record Key: 3dd25101-7923-4996-a97e-b45c6f2d2769
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DentaPure Water Purification Municipal Cartridge
• Version Model Number: *DP365M10
• Company DUNS: 057728685
• Company Name: CROSSTEX INTERNATIONAL, INC.
• Device Count: 10
• DM Exempt: true
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00732224005515 [Unit of Use]
GS1	50732224005510 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992893

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: 2024-09-16
• Device Publish Date: 2022-11-21

Devices Manufactured by CROSSTEX INTERNATIONAL, INC.

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• 00732224005515 - DentaPure Water Purification Municipal Cartridge: 2024-09-16Water Purification Municipal Cartridge
• 00732224005515 - DentaPure Water Purification Municipal Cartridge: 2024-09-16 Water Purification Municipal Cartridge
• 00732224005522 - DentaPure Water Purification Bottle Cartridge: 2024-09-16 Water Purification Bottle Cartridge
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• 20815878025321 - Burkhart Non-Woven Sponges: 2024-04-17
• 20815878027585 - Burkhart Non-Woven Sponges: 2024-04-17
• 20815878027592 - Burkhart Cotton Rolls: 2024-04-17