DentaPure Water Purification Bottle Cartridge

GUDID 00732224005676

International Water Purification Bottle Cartridge

CROSSTEX INTERNATIONAL, INC.

Dental waterline disinfectant cartridge Dental waterline disinfectant cartridge Dental waterline disinfectant cartridge Dental waterline disinfectant cartridge Dental waterline disinfectant cartridge Dental waterline disinfectant cartridge 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