FDA UDI
In Commercial Distribution
🇺🇸 United States
POLIMAX
DI: 07897990300165
·
Model: 0001010001
·
TDV DENTAL LTDA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- POLIMAX
- Primary DI
- 07897990300165
- Version / Model
- 0001010001
- Catalog Number
- 0001010001
- Company Name
- TDV DENTAL LTDA
- Labeler DUNS
- 900580358
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-28
- Public Version
- 1
- Public Version Date
- 2025-03-10
- Public Version Status
- New
- Public Device Record Key
- 6b564d8c-f302-476f-b4f4-3b0c4c268a89
Device Description
POLIMAX - 12 Units + Mandrel (PT/ES/EN/FR)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| EJQ | Wheel, Polishing Agent | Dental | 872.6010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64617 | Dental abrasive disk, single-use | A dental instrument consisting of a circular flat or slightly conical sheet, which may carry or contain an abrasive, intended to perform a circular and/or oscillatory motion for polishing and finishing a cavity preparation and/or for cutting or polishing dental restorations (e.g., dentures, fillings, crowns). It is designed to be fixed at its centre to a laboratory mandrel or lathe, and/or intended to be used with a dental power tool handpiece (e.g., straight or contra-angle). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07897990300165 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 86 Degrees Fahrenheit