Identity
- Trade Name
- Sonicator 718 FDA UDI
- Generic Name
- Physical therapy ultrasound system FDA UDI
- Device Name
- Sonicator 718, 1 MHz, 5.5 cm2, portable ultrasound FDA UDI
- Model / Reference
- ME 718 FDA UDI
- Description
- Sonicator 718, 1 MHz, 5.5 cm2, portable ultrasound FDA UDI
Identifiers
- Catalog Number
- ME 718 FDA UDI
- Primary DI / UDI-DI
- 00816864020265 FDA UDI
- 510(k) Number
- K112520 FDA UDI
- FDA Product Code
- IMI FDA UDI
- GMDN Term
- Physical therapy ultrasound system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5300 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
Dimensions & Sizes
- Size
- Weight — 202 Gram FDA UDI
Category: Physical therapy ultrasound system
Sonicator 718 by Mettler Electronics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K112520 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mettler Electronics Corp.
Sources (1)
- FDA UDI 0cec98ab-88e5-40bf-8ab1-a25a72557761 38 fields · synced Jun 8, 2026