FDA UDI
In Commercial Distribution
🇺🇸 United States
Soan
DI: 03760349805335
·
Model: SOAN1
·
DENTALHITEC
Product Codes
2
GMDN Terms
2
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Soan
- Primary DI
- 03760349805335
- Version / Model
- SOAN1
- Catalog Number
- SOAN1
- Company Name
- DENTALHITEC
- Labeler DUNS
- 640616736
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-22
- Public Version
- 1
- Public Version Date
- 2023-08-30
- Public Version Status
- New
- Public Device Record Key
- a7501893-5779-49ce-8a3d-447f0525ee4d
Device Description
1 Soan handpiece 1 wireless pedal 1 battery charger 1 power supply, 5 containers 1 user manual 2 boxes of dental needles C3022 (primary DI Number: 03760349800507) 1 box of dental needles C3025 (primary DI Number: 03760349800521)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DZM | Needle, Dental | Dental | 872.4730 | 1 |
| EJI | Syringe, Cartridge | Dental | 872.6770 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60599 | Dental computer assisted anaesthesia injection unit | A mains electricity (AC-powered) dental device intended to accurately administer a local anaesthetic agent within the oral cavity for improved analgesic localization and pain reduction. It is typically a bench-top unit with processing software, displays, and controls (e.g., foot-switch) intended to be used in conjunction with a dental anaesthesia cartridge, handpiece, and needle to form a complete computer assisted local anaesthetic delivery system. It is designed to measure and display fluid pressure variations at the needle tip to indicate needle location and aid anaesthetic agent injection; it may also measure fluid volumes and flow rates. | No | Active |
| 12740 | Dental syringe needle, single-use | A sterile, sharp bevel-edged, hollow tubular metal instrument with an integral hub, typically intended to be attached to a dental cartridge syringe for the injection of local anaesthetics. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | 03760349809951 | GS1 | ||||
| Primary | 03760349805335 | GS1 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 30 Degrees Celsius