Identity
- Trade Name
- Injectable RF Electrode 5cm Disposable FDA UDI
- Generic Name
- Open-surgery electrosurgical electrode, monopolar, single-use FDA UDI
- Device Name
- Injectable RF Electrode 5cm Disposable - Sterile FDA UDI
- Model / Reference
- V-5-5-20-B-G2 FDA UDI
- Description
- Injectable RF Electrode 5cm Disposable - Sterile FDA UDI
Identifiers
- Catalog Number
- V-5-5-20B-G2 FDA UDI
- Primary DI / UDI-DI
- 00817771029235 FDA UDI
- 510(k) Number
- K170116 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Open-surgery electrosurgical electrode, monopolar, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Open-surgery electrosurgical electrode, monopolar, single-use
Injectable RF Electrode 5cm Disposable by Celling Biosciences — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Open-surgery electrosurgical electrode, monopolar, single-use.
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- star Bipolar RF Electrode — STARMED CO., LTD · Class IIb
- 4" Blade Tip Ext Ins; Stainless Steel; Blue Ins; Black Ext Ins — XODUS MEDICAL, INC. · Class II
- VIVA RF electrode — STARMED CO., LTD · Class IIb
- CONMED — Conmed Corporation · Class II
Cleared under the same submission
K170116 also covers:
- Injectable RF Electrode 10cm Disposable — Celling Biosciences
- Injectable RF Electrode 10cm Disposable — Celling Biosciences
- Injectable RF Electrode 10cm Disposable — Celling Biosciences
- Injectable RF Electrode 10cm Disposable — Celling Biosciences
- Injectable RF Electrode 10cm Disposable (Qty 5) — Celling Biosciences
- Injectable RF Electrode 10cm Disposable (Qty 5) — Celling Biosciences
- Injectable RF Electrode 20cm Disposable — Celling Biosciences
- Injectable RF Electrode 20cm Disposable — Celling Biosciences
- Injectable RF Electrode 20cm Disposable (Qty 5) — Celling Biosciences
- Injectable RF Electrode 5cm Disposable — Celling Biosciences
- Injectable RF Electrode — Thermi
- Injectable RF Electrode — Thermi
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Celling Biosciences
Sources (1)
- FDA UDI 5dfafb77-e773-42f6-8bee-9e949861c6bc 35 fields · synced Jun 8, 2026