Identity
- Trade Name
- PMI LAPHANDLE FDA UDI
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, monopolar, reusable FDA UDI
- Device Name
- PMI LAPHANDLE, Reusable Monopolar Handle with Integrated Shaft, 33cm FDA UDI
- Model / Reference
- PMILSH33 FDA UDI
- Description
- PMI LAPHANDLE, Reusable Monopolar Handle with Integrated Shaft, 33cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850013527816 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Endoscopic electrosurgical handpiece/electrode, monopolar, reusable 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
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Pmi Laphandle by Dannik LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic electrosurgical handpiece/electrode, monopolar, reusable.
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- Silex — SILEX MEDICAL, LLC · Class II
- AESCULAP — AESCULAP, INC. · Class II
- Signature — SILEX MEDICAL, LLC · Class II
- Dorsey Grasper Inner Shaft — ORANGE SURGICAL INSTRUMENTS, LLC · 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 |
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Manufacturer
- Manufacturer
- Dannik LLC
Sources (1)
- FDA UDI b75e6edc-a010-48bf-8b5e-7b47de5a1e7e 33 fields · synced May 30, 2026