FDA UDI
In Commercial Distribution
🇺🇸 United States
ELRA Electrode
DI: 08809306762399
·
Model: 7-4B18L
·
STARMED CO.,LTD
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- ELRA Electrode
- Primary DI
- 08809306762399
- Version / Model
- 7-4B18L
- Company Name
- STARMED CO.,LTD
- Labeler DUNS
- 694699723
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-04-19
- Public Version
- 1
- Public Version Date
- 2019-04-29
- Public Version Status
- New
- Public Device Record Key
- 14e0aa68-cf1b-454a-8eee-f5820b029d58
Device Description
The ELRA Electrode is a bipolar electrode. The ELRA Electrode is a sterile, single-use electrosurgical accessory intended to be used in conjunction with VIVA combo RF generator (K163450). They are not intended to function with other RF generators. The ELRA Electrode consists of an electrode tip, insulation part, handle. Patient contacting materials of ELRA Electrode are stainless steel 304, Teflon-ETFE, UV adhesive, Nylon, PEEK and polyether block amides.
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
- 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 |
|---|---|---|---|---|
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | Gastroenterology, Urology | 876.4300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61872 | Endoscopic electrosurgical electrode, bipolar, single-use | An invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a bipolar configuration (i.e., without a 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 controlling ring-handles). This is a single-use device intended to be used in a sterile condition. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 28809306762393 | GS1 | Carton | 10 | In Commercial Distribution | |
| Primary | 08809306762399 | GS1 | ||||
| Package | 18809306762396 | GS1 | Carton | 5 | In Commercial Distribution |
Customer Contacts
- Phone
- +82318163546
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Shaft Length | 175 | Centimeter |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 40 Degrees Celsius