FDA UDI
In Commercial Distribution
🇺🇸 United States
Rally™
DI: 00810038093857
·
Model: FPCF040-1
·
GARRISON DENTAL SOLUTIONS, L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Rally™
- Primary DI
- 00810038093857
- Version / Model
- FPCF040-1
- Catalog Number
- FPCF040-1
- Company Name
- GARRISON DENTAL SOLUTIONS, L.L.C.
- Labeler DUNS
- 057647005
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-24
- Public Version
- 1
- Public Version Date
- 2020-05-04
- Public Version Status
- New
- Public Device Record Key
- 25cab727-0097-4b0f-8fce-6a92fb7a3f87
Device Description
Composite Polisher, Fine Grit Cup, Gray
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
- Yes
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| EHJ | Disk, Abrasive | Dental | 872.6010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31833 | Dental abrasive point, reusable | A rotary endpiece designed to be attached to a dental power tool handpiece to produce an abrasive rotation typically for polishing and smoothing natural or restorative dental materials (e.g., crown) during a dental procedure. Also referred to as a polisher, it is available in various forms (e.g., conical), sizes, and materials [e.g., silicone, rubber, metal, diamond, silicon carbide, aluminium oxide]. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810038093857 | GS1 | ||||
| Package | 10810038093854 | GS1 | FPCF040-X | 15 | In Commercial Distribution | |
| Package | 20810038093851 | GS1 | FPCF040 | 15 | In Commercial Distribution |
Customer Contacts
- Phone
- 888-437-0032
- [email protected]