FDA UDI
In Commercial Distribution
🇺🇸 United States
Two Striper
DI: B868CECS01591
·
Model: 300S-ASST
·
ABRASIVE TECHNOLOGY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- Two Striper
- Primary DI
- B868CECS01591
- Version / Model
- 300S-ASST
- Catalog Number
- CECS0159
- Company Name
- ABRASIVE TECHNOLOGY, INC.
- Labeler DUNS
- 054028295
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2022-03-11
- Public Version
- 1
- Public Version Date
- 2022-03-21
- Public Version Status
- New
- Public Device Record Key
- 9939d42e-4c1a-4aaf-8cb0-ebf73c210173
Device Description
Diamond Finishing Strips
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
- No
- 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 |
|---|---|---|---|---|
| EHM | Strip, Polishing Agent | Dental | 872.6010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63358 | Dental abrasive strip, reusable | A manual dental device in the form of a strip coated with abrasive particles on one or both sides intended to be used for modifying (e.g., polishing, finishing, contouring, reducing) the surface of a tooth or restoration during a dental procedure. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | B868CECS01590 | HIBCC | ||||
| Primary | B868CECS01591 | HIBCC |