FDA UDI
In Commercial Distribution
🇺🇸 United States
ERBE
DI: 04050147020191
·
Model: 70132-203
·
Erbe Elektromedizin GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ERBE
- Primary DI
- 04050147020191
- Version / Model
- 70132-203
- Catalog Number
- 70132-203
- Company Name
- Erbe Elektromedizin GmbH
- Labeler DUNS
- 316116623
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-13
- Public Version
- 4
- Public Version Date
- 2023-04-04
- Public Version Status
- Update
- Public Device Record Key
- f73c2bd4-1a43-4876-a968-5b008715ff61
Device Description
FiAPC probe w. filter 2200 A ø 3,6mm; L 2,2m
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
- 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 |
|---|---|---|---|---|---|---|
| Primary | 04050147020191 | GS1 |
Customer Contacts
- Phone
- +4970717550
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K060183 | 000 |