FDA UDI
In Commercial Distribution
🇺🇸 United States
S-N2 CAN-Bus
DI: J021302850001
·
Model: 30285000
·
W & H Dentalwerk Bürmoos GmbH
Product Codes
5
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- S-N2 CAN-Bus
- Primary DI
- J021302850001
- Version / Model
- 30285000
- Company Name
- W & H Dentalwerk Bürmoos GmbH
- Labeler DUNS
- 300238441
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-28
- Public Version
- 2
- Public Version Date
- 2022-06-24
- Public Version Status
- Update
- Public Device Record Key
- c633096a-555f-426e-951f-05314cc3b1e3
Device Description
Foot Control CAN-Bus
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
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | Ear, Nose, Throat | 874.4250 | 2 |
| DZI | Drill, Bone, Powered | Dental | 872.4120 | 2 |
| GEY | Motor, Surgical Instrument, Ac-Powered | General, Plastic Surgery | 878.4820 | 1 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | General, Plastic Surgery | 878.4820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36336 | Foot-switch, electrical | An electrically-powered pedal used by an operator of a medical device to regulate the activation and/or intensity of a parent device (e.g., electrosurgical system generator, laser, ophthalmic examination unit, dental drill/saw system control unit) to which it is connected, typically via an electrical cable. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | J021302850000 | HIBCC | ||||
| Primary | J021302850001 | HIBCC |