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VIVA RF Electrode
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 17-25V05-30XRef 16-08V05-30X_V2Ref 15-15V05-30Ref 15-35V15-40X_V2Ref 17-10V05-30_V2Ref 15-25V05-30XRef 17-25V15-40XRef 17-35V05-30X_V2Ref 15-15V15-40Ref 17-07V15-40X_V2Ref 17-20V05-30Ref 15-35V05-30XRef 15-35V15-40XRef 16-12V05-30X_V2Ref 17-35V15-40Ref 15-10V15-40X_V2Ref 17-15V15-40X_V2Ref 18-07V05-30XRef 17-15V05-30XRef 18-10V05-30XRef 15-15V05-30X_V2Ref 17-20V05-30_V2Ref 15-25V15-40Ref 15-35V05-30Ref 15-20V15-40XRef 17-15V05-30_V2Ref 18-10V05-15X_V2Ref 17-10V05-30X_V2Ref 18-05V05-15X_V2Ref 15-25V05-30Ref 17-15V15-40XRef 18-15V15-40X_V2Ref 16-25V05-30X_V2Ref 17-20V15-40Ref 16-15V15-40X_V2Ref 17-20V15-40_V2Ref 16-10V15-40X_V2Ref 19-10V05-15X_V2Ref 17-35V05-30XRef 17-10V15-40X_V2Ref 16-35V05-30X_V2Ref 15-25V15-40X_V2Ref 18-07V05-15X_V2Ref 16-12V15-40X_V2
Identity
- Trade Name
- VIVA RF Electrode EUDAMEDFDA UDI
- Generic Name
- Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar FDA UDI
- Device Name
- VIVA RF Electrode EUDAMEDThe VIVA RF Electrode is a sterile, single-use electrosurgical accessory intended to be used in conjunction with VIVA combo RF Generator. This electrode comprises an electrode tip, handle and tubing. FDA UDI
- Model / Reference
- 17-25V05-30X EUDAMED16-08V05-30X_V2 EUDAMED15-15V05-30 EUDAMED15-35V15-40X_V2 EUDAMED17-10V05-30_V2 EUDAMED15-25V05-30X EUDAMED17-25V15-40X EUDAMED17-35V05-30X_V2 EUDAMED15-15V15-40 EUDAMED17-07V15-40X_V2 EUDAMED17-20V05-30 EUDAMED15-35V05-30X EUDAMED15-35V15-40X EUDAMED16-12V05-30X_V2 EUDAMED17-35V15-40 EUDAMED15-10V15-40X_V2 EUDAMED17-15V15-40X_V2 EUDAMED18-07V05-30X EUDAMEDFDA UDI17-15V05-30X EUDAMEDFDA UDI18-10V05-30X EUDAMEDFDA UDI15-15V05-30X_V2 EUDAMEDFDA UDI17-20V05-30_V2 EUDAMED15-25V15-40 EUDAMED15-35V05-30 EUDAMED15-20V15-40X EUDAMED17-15V05-30_V2 EUDAMED18-10V05-15X_V2 EUDAMED17-10V05-30X_V2 EUDAMED18-05V05-15X_V2 EUDAMED15-25V05-30 EUDAMED17-15V15-40X EUDAMED18-15V15-40X_V2 EUDAMED16-25V05-30X_V2 EUDAMED17-20V15-40 EUDAMED16-15V15-40X_V2 EUDAMED17-20V15-40_V2 EUDAMED16-10V15-40X_V2 EUDAMED19-10V05-15X_V2 EUDAMED17-35V05-30X EUDAMED17-10V15-40X_V2 EUDAMED16-35V05-30X_V2 EUDAMED15-25V15-40X_V2 EUDAMED18-07V05-15X_V2 EUDAMED16-12V15-40X_V2 EUDAMED
- Description
- The VIVA RF Electrode is a sterile, single-use electrosurgical accessory intended to be used in conjunction with VIVA combo RF Generator. This electrode comprises an electrode tip, handle and tubing. FDA UDI
Identifiers
- Catalog Number
- 17-15V05-30X FDA UDI
- Primary DI / UDI-DI
- 08809306760241 EUDAMED08809306763051 EUDAMED08809306761477 EUDAMED08809306763488 EUDAMED08809306762917 EUDAMED08809306761408 EUDAMED08809306761347 EUDAMED08809306762856 EUDAMED08809306760173 EUDAMED08809306762740 EUDAMED08809306760135 EUDAMED08809306761415 EUDAMED08809306760319 EUDAMED08809306763099 EUDAMED08809306761460 EUDAMED08809306763402 EUDAMED08809306762818 EUDAMED08809306760197 EUDAMEDFDA UDI08809306760227 EUDAMEDFDA UDI08809306761323 EUDAMEDFDA UDI08809306768322 EUDAMEDFDA UDI08809306762979 EUDAMED08809306761507 EUDAMED08809306765826 EUDAMED08809306760296 EUDAMED08809306762955 EUDAMED08809306764188 EUDAMED08809306762771 EUDAMED08809306764164 EUDAMED08809306761491 EUDAMED08809306760258 EUDAMED08809306762504 EUDAMED08809306763150 EUDAMED08809306760166 EUDAMED08809306763129 EUDAMED08809306762986 EUDAMED08809306763082 EUDAMED08809306764157 EUDAMED08809306761354 EUDAMED08809306762788 EUDAMED08809306763174 EUDAMED08809306763464 EUDAMED08809306764089 EUDAMED08809306763105 EUDAMED
- Basic UDI-DI
- 880930676VIVA_EWD EUDAMEDB-08809306761477 EUDAMEDB-08809306761408 EUDAMEDB-08809306761347 EUDAMEDB-08809306760173 EUDAMEDB-08809306760135 EUDAMEDB-08809306763402 EUDAMEDB-08809306762818 EUDAMEDB-08809306760197 EUDAMEDB-08809306760227 EUDAMEDB-08809306768322 EUDAMEDB-08809306762979 EUDAMEDB-08809306762955 EUDAMEDB-08809306761491 EUDAMEDB-08809306762504 EUDAMEDB-08809306760166 EUDAMEDB-08809306763129 EUDAMEDB-08809306762986 EUDAMEDB-08809306762788 EUDAMEDB-08809306763174 EUDAMEDB-08809306763464 EUDAMEDB-08809306761415 EUDAMEDB-08809306762856 EUDAMEDB-08809306763150 EUDAMEDB-08809306762771 EUDAMEDB-08809306761323 EUDAMEDB-08809306765826 EUDAMEDB-08809306760296 EUDAMEDB-08809306760258 EUDAMEDB-08809306763105 EUDAMEDB-08809306762740 EUDAMEDB-08809306761354 EUDAMEDB-08809306760241 EUDAMED
- 510(k) Number
- K172012 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- K0201010301 OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMED
- GMDN Term
- Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Bulgaria EUDAMEDFrance EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 18 Gauge FDA UDILength — 7 Centimeter FDA UDILength — 10 Centimeter FDA UDINeedle Gauge — 15 Gauge FDA UDILength — 15 Centimeter FDA UDINeedle Gauge — 17 Gauge FDA UDI
Category: Open-surgery electrosurgical electrode, monopolar, single-use
VIVA RF Electrode by Starmed Co., Ltd — Class IIb — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 880930676VIVA_EWD | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 880930676VIVA_EWD | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- STARmed Co., Ltd.
- EUDAMED SRN
- KR-MF-000008605
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (75)
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