FDA UDI
In Commercial Distribution
🇺🇸 United States
CONMED
DI: 20653405081972
·
Model: AES-WFC
·
Conmed Corporation
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- CONMED
- Primary DI
- 20653405081972
- Version / Model
- AES-WFC
- Catalog Number
- AES-WFC
- Company Name
- Conmed Corporation
- Labeler DUNS
- 071595540
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-05
- Public Version
- 2
- Public Version Date
- 2024-03-27
- Public Version Status
- Update
- Public Device Record Key
- 235c3d36-00d0-4850-8efa-f876851851ce
Device Description
ARTHROSCOPIC ENERGY FOOT WIRELESS CONTROL
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 |
|---|---|---|---|---|
| GEI | Electrosurgical, cutting & coagulation & accessories | General, Plastic Surgery | 878.4400 | 2 |
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 | 40653405081976 | GS1 | ||||
| Previous | 30653405081979 | GS1 | ||||
| Primary | 20653405081972 | GS1 |
Customer Contacts
- Phone
- +1(866)426-6633
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K153499 | 000 |