FDA UDI
In Commercial Distribution
🇺🇸 United States
X-CUBE
DI: 08809260470200
·
Model: TRAUS CRB26XX
·
Saeshin Precision Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- X-CUBE
- Primary DI
- 08809260470200
- Version / Model
- TRAUS CRB26XX
- Company Name
- Saeshin Precision Co., Ltd.
- Labeler DUNS
- 688019566
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-01-22
- Public Version
- 1
- Public Version Date
- 2020-01-30
- Public Version Status
- New
- Public Device Record Key
- 36fd82e0-9eb8-483d-a990-98b63053c143
Device Description
Angle Handpiece 92.7(L) x 20.0(D)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| EKY | Handpiece, Water-Powered | Dental | 872.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45572 | Dental power tool system, line-powered | An assembly of devices designed to both bore/excavate and saw bones, teeth, and tough tissues during a dental/maxillofacial surgical procedure. It typically consists of a motorized handpiece and/or motor, a control unit, and a variety of attachments used to hold the cutting instruments (e.g., drill bits, saw blades, burs, polishing disks). The system is electrically-powered from the mains (e.g., 230 or 115 volt) and supplies the handpiece/motor with low-voltage electricity (e.g., 24 volt) through the control unit. The system may operate through a dental delivery system or be freestanding and independent. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08809260470200 | GS1 |