Avalon Biomed NeoSEALER Flo 2.2 g Refill Syringe

Basic Information

• Brand Name: Avalon Biomed NeoSEALER Flo 2.2 g Refill Syringe
• Primary DI: 00810092938286
• Version / Model: ANSRS
• Company Name: NUSMILE, LTD.
• Labeler DUNS: 185497372
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-17
• Public Version: 2
• Public Version Date: 2023-06-29
• Public Version Status: Update
• Public Device Record Key: 68128804-5df9-4d62-911d-56f521ac5642

Device Description

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
60510	Hygroscopic dental cement	A substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material, root canal sealer) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction of a hygroscopic inorganic compound(s) [e.g., calcium silicates, calcium aluminates, zinc sulfate, calcium sulfate] with water (hydration). It is intended to be either mixed with water prior to application or react with dentinal fluid in situ. After application, this device cannot be reused.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810092938286	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Weight	2.2	Gram

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 72 – Degrees Fahrenheit