FDA UDI
In Commercial Distribution
🇺🇸 United States
Castellini
DI: 08033837933885
·
Model: PUMA ELI A R CART
·
CEFLA SOCIETA' COOPERATIVA
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Castellini
- Primary DI
- 08033837933885
- Version / Model
- PUMA ELI A R CART
- Catalog Number
- 71LCXXXX
- Company Name
- CEFLA SOCIETA' COOPERATIVA
- Labeler DUNS
- 429341410
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-11-08
- Public Version
- 1
- Public Version Date
- 2021-11-16
- Public Version Status
- New
- Public Device Record Key
- 6f5f18a6-15e2-464f-9625-660dc0c2562f
Device Description
The device is a dental unit consisting of components and/or devices that are functionally connected, such as the dental unit, dental handpieces, multifunction pedal. The dentist board is mounted on a mobile cart equipped with wheels, mechanically separated from the rest of the dental unit but electrically connected to it. The last four characters "XXXX" of the catalog number can be different alphanumeric characters.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| ELC | Scaler, Ultrasonic | Dental | 872.4850 | 2 |
| EIA | Unit, Operative Dental | Dental | 872.6640 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34991 | Dental delivery system | A stationary, mains electricity (AC-powered) device assembly designed to provide dental staff with the necessary utilities/amenities to deliver dental treatment to a patient. The utilities/amenities are typically compressed air, water, suction, electricity, table top or bracket table surfaces, cuspidor, gas, and sometimes the dental light. This is a fixed-position system (i.e., not mobile) which incorporates an instrument unit for dental instrument provision. The patient examination/treatment chair is typically integrated as part of this system. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08033837933885 | GS1 |
Customer Contacts
- Phone
- +1 (704)598-0020
- [email protected]
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 70 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 75 Percent (%) Relative Humidity