Identity
- Trade Name
- Signature Series FDA UDI
- Generic Name
- Electrosurgical system FDA UDI
- Device Name
- Electrosurgical Devices, Roller Ball FDA UDI
- Model / Reference
- M0068802650 FDA UDI
- Description
- Electrosurgical Devices, Roller Ball FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08714729890201 FDA UDI
- FDA Product Code
- FAS FDA UDI
- GMDN Term
- Electrosurgical system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.4300 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
Dimensions & Sizes
- Size
- Catheter Gauge — 24 French FDA UDIOuter Diameter — 5.0 Millimeter FDA UDI
Category: Electrosurgical system
Signature Series by Prosurg, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electrosurgical system.
- Bovie — BOVIE MEDICAL CORPORATION · Class II
- Macan — Macan Manufacturing · Class II
- Macan — Macan Manufacturing · Class II
- T4 Fine wire electrode — BONART CO., LTD. · Class II
- DIEGO ELITE — Gyrus Acmi, Inc. · Class II
- Macan — Macan Manufacturing · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- Bovie — BOVIE MEDICAL CORPORATION · 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
- Prosurg, Inc
Sources (1)
- FDA UDI d0aa372e-1916-4e76-b8bf-fe9c34a36bee 35 fields · synced May 30, 2026