FDA UDI
In Commercial Distribution
🇺🇸 United States
COXO
DI: 06974267891067
·
Model: C-PUMA MASTER
·
Foshan COXO Medical Instrument Co.,Ltd.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- COXO
- Primary DI
- 06974267891067
- Version / Model
- C-PUMA MASTER
- Company Name
- Foshan COXO Medical Instrument Co.,Ltd.
- Labeler DUNS
- 529860171
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-30
- Public Version
- 1
- Public Version Date
- 2024-04-08
- Public Version Status
- New
- Public Device Record Key
- 9c186500-27ae-499b-b9ed-708e04cc556a
Device Description
Dental Electrical Motors
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| EBW | Controller, Foot, Handpiece And Cord | Dental | 872.4200 | 1 |
| KMW | Handpiece, Rotary Bone Cutting | Dental | 872.4120 | 2 |
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | Dental | 872.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66227 | Dental surgical power tool motor, electric | A hand-held, electrically-powered component of a dental power tool assembly designed to convert electrical energy into a non-dedicated mechanical energy for drilling or sawing during dental surgery. It is designed to accept handpiece components/attachments (not included) and is not intended to directly accept an endpiece (e.g., drill bit, saw blade). It might be operated with a hand- or foot-switch. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06974267891067 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K220831 | 000 |