Identity
- Trade Name
- Diego FDA UDI
- Generic Name
- Electrosurgical handpiece, reusable FDA UDI
- Device Name
- DIEGO TRIGGER SWITCH STERILE, DISPOSABLE FDA UDI
- Model / Reference
- 70338008 FDA UDI
- Description
- DIEGO TRIGGER SWITCH STERILE, DISPOSABLE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821925034143 FDA UDI
- 510(k) Number
- K020594 FDA UDI
- FDA Product Code
- ERL FDA UDI
- GMDN Term
- Electrosurgical handpiece, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4250 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
Category: Electrosurgical handpiece, reusable
Diego by Gyrus Acmi, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K020594 also covers:
- DIEGO — Gyrus Acmi, Inc.
- DIEGO — Gyrus Acmi, Inc.
- DIEGO — Gyrus Acmi, Inc.
- DIEGO — Gyrus Acmi, Inc.
- DIEGO — Gyrus Acmi, Inc.
- DIEGO — Gyrus Acmi, Inc.
- DIEGO ELITE — Gyrus Acmi, Inc.
- DIEGO ELITE — Gyrus Acmi, Inc.
- Diego — Gyrus Acmi, Inc.
- Diego — Gyrus Acmi, Inc.
- Diego — Gyrus Acmi, Inc.
- Diego — Gyrus Acmi, Inc.
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
- Gyrus Acmi, Inc.
Sources (1)
- FDA UDI fd98c7c6-9327-4a9e-926f-fdb38b220f38 34 fields · synced May 31, 2026