Identity
- Trade Name
- Drum Applicator 3980 FDA UDI
- Generic Name
- Short-wave diathermy treatment system generator FDA UDI
- Device Name
- 14 cm diameter drum applicator FDA UDI
- Model / Reference
- 3980 FDA UDI
- Description
- 14 cm diameter drum applicator FDA UDI
Identifiers
- Catalog Number
- 3980 FDA UDI
- Primary DI / UDI-DI
- 00816864020531 FDA UDI
- 510(k) Number
- K042554 FDA UDI
- FDA Product Code
- IMJ FDA UDI
- GMDN Term
- Short-wave diathermy treatment system generator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5290 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
No
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
Category: Short-wave diathermy treatment system generator
Drum Applicator 3980 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
K042554 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
- Mettler Electronics Corp.
Sources (1)
- FDA UDI 986a1ca8-efc5-4ef8-8e89-7627274a284b 37 fields · synced May 31, 2026