Identity
- Trade Name
- Gyrus ACMI FDA UDI
- Generic Name
- Electrosurgical system FDA UDI
- Device Name
- GYRUS ENT G3 FOOTSWITCH 2-PEDAL FDA UDI
- Model / Reference
- 7035-3002 FDA UDI
- Description
- GYRUS ENT G3 FOOTSWITCH 2-PEDAL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821925010864 FDA UDI
- 510(k) Number
- K041285 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Electrosurgical system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Gyrus ACMI by Gyrus Acmi, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K041285 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
- Gyrus Acmi, Inc.
Sources (1)
- FDA UDI b714cb39-b1e0-4e08-b20b-ccdbf2c5420d 35 fields · synced May 31, 2026