FDA UDI
In Commercial Distribution
🇺🇸 United States
ERBE
DI: 04050147018327
·
Model: 20150-103
·
Erbe Elektromedizin GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ERBE
- Primary DI
- 04050147018327
- Version / Model
- 20150-103
- Catalog Number
- 20150-103
- Company Name
- Erbe Elektromedizin GmbH
- Labeler DUNS
- 316116623
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-14
- Public Version
- 4
- Public Version Date
- 2024-02-09
- Public Version Status
- Update
- Public Device Record Key
- f816eeb0-5cd0-4403-852b-5f700d60cecc
Device Description
ERBEJET® 2 two pedal footsw. w/ReMode; AP & IP X8 Equipment
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
- No
- 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 |
|---|---|---|---|---|
| FQH | LAVAGE, JET | General Hospital | 880.5475 | 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 |
|---|---|---|---|---|---|---|
| Primary | 04050147018327 | GS1 |
Customer Contacts
- Phone
- +4970717550
- [email protected]
Premarket Submissions
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from heat and direct sunlight
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry