FDA UDI
In Commercial Distribution
🇺🇸 United States
E-LINE
DI: 00814334022283
·
Model: 84160105US
·
Richard Wolf GmbH
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- E-LINE
- Primary DI
- 00814334022283
- Version / Model
- 84160105US
- Catalog Number
- 84160105US
- Company Name
- Richard Wolf GmbH
- Labeler DUNS
- 315304071
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2022-12-27
- Public Version
- 2
- Public Version Date
- 2023-08-15
- Public Version Status
- Update
- Public Device Record Key
- d8e4983e-5d41-4348-8d6e-8f9d35c631f0
Device Description
COAG ELECTRODE 11.5FR MONO 0°
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| HIH | HYSTEROSCOPE (AND ACCESSORIES) | Obstetrics/Gynecology | 884.1690 | 2 |
| FAS | ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL | Gastroenterology, Urology | 876.4300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61875 | Endoscopic electrosurgical electrode, monopolar, single-use | A sterile, invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include ring-handles); it is not intended for gas-enhanced electrosurgery. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00814334022290 | GS1 | ||||
| Primary | 00814334022283 | GS1 |
Customer Contacts
- Phone
- +497043350
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Angle | 0 | degree | |
| Outer Diameter | 3.83333333333 | Millimeter |