FDA UDI
In Commercial Distribution
🇺🇸 United States
ERGO
DI: 10845854013144
·
Model: D4240
·
Conmed Corporation
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- ERGO
- Primary DI
- 10845854013144
- Version / Model
- D4240
- Catalog Number
- D4240
- Company Name
- Conmed Corporation
- Labeler DUNS
- 071595540
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-24
- Public Version
- 1
- Public Version Date
- 2026-04-01
- Public Version Status
- New
- Public Device Record Key
- c7a641f9-0067-4b5b-997b-24b0d1fda6a0
Device Description
ERGO 2-BUTTON SHAVER HANDPIECE
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 |
|---|---|---|---|---|
| GEY | MOTOR, SURGICAL INSTRUMENT, AC-POWERED | General, Plastic Surgery | 878.4820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53617 | Arthroscopic shaver system handpiece, electrically-powered | A handle with attached cutting blade that is a component of an electrically-powered arthroscopic shaver system designed for bone and soft-tissue resection during arthroscopic surgery on a joint (e.g., a knee, shoulder, or ankle). It is typically connected to and regulated by a dedicated control unit. It may facilitate additional functions of the system (e.g., irrigation/suction) and is used in combination with appropriate endoscopic devices. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | 30845854013148 | GS1 | ||||
| Previous | 20845854013141 | GS1 | ||||
| Primary | 10845854013144 | GS1 |
Customer Contacts
- Phone
- +1(866)426-6633
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -4 – 158 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 70 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 93 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal