NeoSEALER EZFlo (0.5 g Syringe + 4 Tips) Mini Kit

GUDID 00810118105593

For use in obturating root canals as part of orthograde root canal therapy with gutta percha.

NUSMILE, LTD.

Hygroscopic dental cement

• Primary Device ID: 00810118105593
• NIH Device Record Key: fbefbd25-fc55-4dba-8add-7daf0009b0bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeoSEALER EZFlo (0.5 g Syringe + 4 Tips) Mini Kit
• Version Model Number: ANSEZFM
• Company DUNS: 185497372
• Company Name: NUSMILE, LTD.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• 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 Dimensions

• Weight: 0.5 Gram
• Weight: 0.5 Gram
• Weight: 0.5 Gram
• Weight: 0.5 Gram
• Weight: 0.5 Gram
• Weight: 0.5 Gram
• Weight: 0.5 Gram
• Weight: 0.5 Gram
• Weight: 0.5 Gram
• Weight: 0.5 Gram
• Weight: 0.5 Gram
• Weight: 0.5 Gram
• Weight: 0.5 Gram
• Weight: 0.5 Gram

Operating and Storage Conditions

• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 0 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810118105593 [Primary]

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: 2025-03-18
• Device Publish Date: 2025-03-10

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