Identity
- Trade Name
- Gyrus ACMI FDA UDI
- Generic Name
- Electrohydraulic lithotripsy system FDA UDI
- Device Name
- INCLUDED IN AEH-4/AUTOCLAVE EXTEND CABLE FDA UDI
- Model / Reference
- AEH-4EC FDA UDI
- Description
- INCLUDED IN AEH-4/AUTOCLAVE EXTEND CABLE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821925008502 FDA UDI
- FDA Product Code
- FFK FDA UDI
- GMDN Term
- Electrohydraulic lithotripsy system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.4480 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
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
- Gyrus Acmi, Inc.
Sources (1)
- FDA UDI b37b21d7-19ff-4c2d-ba95-d73bd9002b18 34 fields · synced May 29, 2026