FDA UDI
In Commercial Distribution
🇺🇸 United States
Maquira
DI: 07898938244985
·
Model: CONE POSITIONER KIT ENDO + CHEMICAL STERELIZATION
·
Maquira Industria de Produtos Odontologicos S/A
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Maquira
- Primary DI
- 07898938244985
- Version / Model
- CONE POSITIONER KIT ENDO + CHEMICAL STERELIZATION
- Catalog Number
- 80322400054
- Company Name
- Maquira Industria de Produtos Odontologicos S/A
- Labeler DUNS
- 679266866
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-07
- Public Version
- 1
- Public Version Date
- 2024-08-15
- Public Version Status
- New
- Public Device Record Key
- 196246ac-6303-44ee-b4ac-cd3ebd69495f
Device Description
The CONE POSITIONER is a product used to help guide the angle of the dental X-ray machine in periodontics, endodontics and implantology procedures with or without absolute isolation, resulting in standardized and clear radiographic images.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EGZ | Holder, Film, X-Ray | Dental | 872.1905 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61131 | Radiological general body-part positioner | A device intended to facilitate adequate positioning and immobilization of a patient’s body part during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures; it is not dedicated to a specific part of the body. The device is in the form of a frame, board, cushion, or preformed pad that may also be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07898938244985 | GS1 |