Identity
- Trade Name
- Renuvion®/J-Plasma® FDA UDI
- Generic Name
- Electrosurgical handpiece, single-use FDA UDI
- Device Name
- Renuvion®/J-Plasma Precise® Blade Tip, 5mm-Ø, 27cm-Length, Pistol Grip FDA UDI
- Model / Reference
- APYX-270B FDA UDI
- Description
- Renuvion®/J-Plasma Precise® Blade Tip, 5mm-Ø, 27cm-Length, Pistol Grip FDA UDI
Identifiers
- Catalog Number
- APYX-270B FDA UDI
- Primary DI / UDI-DI
- 00607151050016 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Electrosurgical handpiece, 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
No
FDA UDI
MR Unsafe FDA UDI
Category: Electrosurgical handpiece, single-use
Renuvion®/J-Plasma® by Apyx Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electrosurgical handpiece, single-use.
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- ES Pencil Rocker;2.6" Blade Tip; Stainless Steel; Blue Insulation — XODUS MEDICAL, INC. · Class II
- ES Pencil Rocker 2.75" Blade Electrode Stainless Steel — XODUS MEDICAL, INC. · Class II
- ES Pencil Button;; 2.75" Needle Tip; Blue PTFE; Blue Insulation — XODUS MEDICAL, INC. · Class II
- BOVIE — BOVIE MEDICAL CORPORATION · Class II
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
- Plasma IQ Docking Station — NEAUVIA NORTH AMERICA, INC · Class II
- ES Pencil Button 4" Blade Electrode Ext Insulation PTFE Coated — XODUS MEDICAL, INC. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Apyx Medical Corporation
Sources (1)
- FDA UDI 5c78441b-2205-4af4-802e-d0c5bcb6710a 35 fields · synced Jun 9, 2026