FDA UDI
In Commercial Distribution
🇺🇸 United States
ultrapro Tx air
DI: 00883205028068
·
Model: 8505-
·
ULTRADENT PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- ultrapro Tx air
- Primary DI
- 00883205028068
- Version / Model
- 8505-
- Catalog Number
- 8505-
- Company Name
- ULTRADENT PRODUCTS, INC.
- Labeler DUNS
- 013369913
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-07-02
- Public Version
- 4
- Public Version Date
- 2022-08-22
- Public Version Status
- Update
- Public Device Record Key
- 782f9194-b915-4d6b-832f-92aca20b9829
Device Description
Ultrapro Tx Air Blue Nose Cone Kit
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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EFB | Handpiece, air-powered, dental | Dental | 872.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62725 | Dental delivery system instrument unit, pneumatic | A pneumatically-powered device designed to make available the necessary instruments/equipment and power to deliver dental treatment to a patient. It consists of a platform for the display of a selection of powered dental instruments (e.g., motor handpiece, scaler, suction, air/water spray), sometimes with a control panel for setting various operating parameters; it may be portable or mounted. The device is commonly referred to as a dental unit or dental operative unit and is intended to be operated by a healthcare professional in a medical facility. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00883205028068 | GS1 | ||||
| Direct Marking | 00883205033369 | GS1 |
Customer Contacts
- Phone
- +1(801)572-4200
- [email protected]