FDA UDI
In Commercial Distribution
🇺🇸 United States
MAXSO
DI: 00990010301726
·
Model: MT6002
·
Beyes Dental Canada Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MAXSO
- Primary DI
- 00990010301726
- Version / Model
- MT6002
- Catalog Number
- M600B
- Company Name
- Beyes Dental Canada Inc
- Labeler DUNS
- 244261462
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-11
- Public Version
- 1
- Public Version Date
- 2023-05-19
- Public Version Status
- New
- Public Device Record Key
- fe353a1a-afad-45c7-8e74-46b8c607b394
Device Description
M600B (Built-In),Control Unit, Display Unit, Autoclavable Brushless Motor, Cord for Micromotor
Device Characteristics
- Single Use
- Yes
- 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
- MR Safe
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EBW | Controller, Foot, Handpiece And Cord | Dental | 872.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66245 | Dental surgical power tool motorized handpiece/set, electric | An electrically-powered one-piece device or modular device collection designed to accept an endpiece(s) [e.g., drill bit, saw blade] for drilling, cutting, polishing, and/or inserting procedures involving bones and tough tissues during a dental surgical procedure. It includes an electric motor and the appropriate attachments (e.g., angle adaptor, torque multiplier) at its distal end for connection of the endpieces and may include a rechargeable battery or a control unit; the endpieces are not included. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00990010301726 | GS1 |