Identity
- Trade Name
- Sonicision FDA UDI
- Generic Name
- Soft-tissue ultrasonic surgical system FDA UDI
- Device Name
- Cordless Ultrasonic Dissector FDA UDI
- Model / Reference
- SCD396 FDA UDI
- Description
- Cordless Ultrasonic Dissector FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20884521052663 FDA UDI
- 510(k) Number
- K101797 FDA UDI
- FDA Product Code
- LFL FDA UDI
- GMDN Term
- Soft-tissue ultrasonic surgical system FDA UDI
Classification
- Device Class
- U 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
- Length — 39 Centimeter FDA UDI
Category: Soft-tissue ultrasonic surgical system
Sonicision by Covidien LP — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K101797 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 U | Pending data |
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Manufacturer
- Manufacturer
- Covidien LP
Sources (1)
- FDA UDI 2e050be0-76e2-4fe4-95e4-7910c720637b 37 fields · synced May 30, 2026