FDA UDI
In Commercial Distribution
🇺🇸 United States
Erbe
DI: 04050147024496
·
Model: 20132-254
·
Erbe Elektromedizin GmbH
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Erbe
- Primary DI
- 04050147024496
- Version / Model
- 20132-254
- Catalog Number
- 20132-254
- Company Name
- Erbe Elektromedizin GmbH
- Labeler DUNS
- 316116623
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-29
- Public Version
- 1
- Public Version Date
- 2025-05-07
- Public Version Status
- New
- Public Device Record Key
- 9f7b9874-6b42-49f1-a52d-aecfcd8e9cf1
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
- 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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- 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 |
|---|---|---|---|---|
| 61878 | Inert gas-enhanced endoscopic electrosurgical electrode, single-use | An invasive, distal component of an inert gas-enhanced electrosurgical system intended to deliver electrosurgical current within a stream of inert gas [e.g., argon (Ar), helium (He)] directly to tissues for cutting/coagulation/ablation during an endoscopic (including laparoscopic, arthroscopic) surgical procedure. It is a long thin device with no controls, typically designed as a coaxial arrangement of a monopolar electrode within a gas delivery tube/sleeve, which requires a patient contact return electrode to complete the circuit. It is available in a variety of forms (e.g., rigid laparoscopic electrode, flexible endoscopic probe). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04050147024502 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 04050147024496 | GS1 | ||||
| Previous | 04050147018174 | GS1 |
Customer Contacts
- Phone
- +4970717550
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K183445 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 350 | Millimeter | |
| Outer Diameter | 5 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from heat and direct sunlight