Identity
- Trade Name
- ZIP Pen FDA UDI
- Generic Name
- Electrosurgical system generator FDA UDI
- Device Name
- Zip Pen Extension Nozzle 2.7" (6.8 cm) FDA UDI
- Model / Reference
- 2540 FDA UDI
- Description
- Zip Pen Extension Nozzle 2.7" (6.8 cm) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10614559104187 FDA UDI
- 510(k) Number
- K141587 FDA UDI
- FDA Product Code
- FYD FDA UDI
- GMDN Term
- Electrosurgical system generator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.5070 FDA UDI
- Commercial Distribution
- Not 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
Radiation Sterilization FDA UDI
ZIP Pen by Megadyne Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K141587 also covers:
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
- Megadyne Medical Products, Inc.
Sources (1)
- FDA UDI 317c1eef-0e11-481d-b5dc-8c720c2100f9 37 fields · synced Jun 9, 2026