Avalon Biomed NeoSEALER Flo 2.2gm Refill Syringe
- Primary DI
- 00810092938286
- Brand
- Avalon Biomed NeoSEALER Flo 2.2gm Refill Syringe
- Company
- NUSMILE, LTD.
- Model
- ANSRS
- Device description
- For use in obturating root canals as part of orthograde root canal therapy with gutta percha.
- Published
- 2022-05-17
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00810092938286 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00810092938286 | 00810092938286 | 810092938286 | 0810092938286 |
GMDN Terms
| Term | Definition |
|---|
| 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. |
Device Sizes
| Type | Value | Unit |
|---|
| Weight | 2.2 | Gram |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | 72 Degrees Fahrenheit | 0 Degrees Fahrenheit | |
Regulatory Flags
- DUNS number
- 185497372
- Device count
- 1
- DM exempt
- true
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
nusmile.com