FDA UDI
In Commercial Distribution
🇺🇸 United States
Two Striper
DI: B868C8400461
·
Model: STAINBUSTER 4002 6-BUR PACK
·
ABRASIVE TECHNOLOGY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
6
Basic Information
- Brand Name
- Two Striper
- Primary DI
- B868C8400461
- Version / Model
- STAINBUSTER 4002 6-BUR PACK
- Catalog Number
- C840046
- Company Name
- ABRASIVE TECHNOLOGY, INC.
- Labeler DUNS
- 054028295
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2021-05-25
- Public Version
- 1
- Public Version Date
- 2021-06-02
- Public Version Status
- New
- Public Device Record Key
- c0c6c475-cb81-40cc-990f-81d22f178e04
Device Description
Abrasive Point
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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| EHL | POINT, ABRASIVE | Dental | 872.6010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58073 | Polymeric dental bur | A rotary device intended to be attached to a slow speed dental handpiece that provides the rotation to enable the device to remove infected/decayed dentin without harming healthy zones of dentin. It is made of glass-bead-reinforced polymer or polyetheretherketone (PEEK) designed to deform on encountering harder, healthy dentin. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | B868C8400460 | HIBCC | ||||
| Primary | B868C8400461 | HIBCC |