Identity
- Trade Name
- Pen FDA UDI
- Generic Name
- Soft-tissue ultrasonic surgical system handpiece, reusable FDA UDI
- Device Name
- Micro instrument, irrigation FDA UDI
- Model / Reference
- 91-021 FDA UDI
- Description
- Micro instrument, irrigation FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250321519125 FDA UDI
- 510(k) Number
- K992026 FDA UDI
- FDA Product Code
- BTA FDA UDI
- GMDN Term
- Soft-tissue ultrasonic surgical system handpiece, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4780 FDA UDI
- Commercial Distribution
- Not 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
Dimensions & Sizes
- Size
- Outer Diameter — 1.4 Millimeter FDA UDILength — 121 Millimeter FDA UDI
Pen by Söring GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K992026 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
- Söring GmbH
Sources (1)
- FDA UDI ae411876-0b6e-4cad-9cf7-bc11b716fef7 37 fields · synced May 30, 2026