Identity
- Trade Name
- MiSeal FDA UDI
- Generic Name
- Electrosurgical handpiece, reusable FDA UDI
- Device Name
- Thermal Ligating Shears Kit, Disposable FDA UDI
- Model / Reference
- 452-131D FDA UDI
- Description
- Thermal Ligating Shears Kit, Disposable FDA UDI
Identifiers
- Catalog Number
- 452-131D FDA UDI
- Primary DI / UDI-DI
- 00811099011569 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Electrosurgical handpiece, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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
The MiSeal device is a hand-held, reusable electrosurgical tool designed for general plastic surgery procedures. It features a thermally controlled ligating shears mechanism that provides precise cutting and coagulation capabilities.
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
- Microline Surgical, Inc.
Sources (1)
- FDA UDI 97e29251-64f2-424b-a585-c26a503e6272 35 fields · synced Jul 2, 2026