DentaPure Water Purification Bottle Cartridge

GUDID 00732224005676

International Water Purification Bottle Cartridge

CROSSTEX INTERNATIONAL, INC.

Dental waterline disinfectant cartridge

• Primary Device ID: 00732224005676
• NIH Device Record Key: 8aaf33fb-e1ae-41d0-be61-042e0c88ab3f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DentaPure Water Purification Bottle Cartridge
• Version Model Number: DPI365B10
• Company DUNS: 057728685
• Company Name: CROSSTEX INTERNATIONAL, INC.
• Device Count: 10
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00732224005676 [Unit of Use]
GS1	50732224005671 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-16
• Device Publish Date: 2024-04-08

On-Brand Devices [DentaPure Water Purification Bottle Cartridge]

• 00732224005676: International Water Purification Bottle Cartridge
• 10732224005673: International Water Purification Bottle Cartridge