FDA UDI
In Commercial Distribution
🇺🇸 United States
Avalon Biomed NeoSEALER Flo 2.2 g w/ 20 Flex Flo Tips
DI: 00810092930846
·
Model: ANSFK
·
NUSMILE, LTD.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Avalon Biomed NeoSEALER Flo 2.2 g w/ 20 Flex Flo Tips
- Primary DI
- 00810092930846
- Version / Model
- ANSFK
- Company Name
- NUSMILE, LTD.
- Labeler DUNS
- 185497372
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-09-02
- Public Version
- 3
- Public Version Date
- 2023-08-04
- Public Version Status
- Update
- Public Device Record Key
- 3335a6d9-c984-4d0a-897e-db2fde5bb084
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 | 00810092930846 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 2.2 | Gram |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 72 – Degrees Fahrenheit