Identity
- Trade Name
- Gyrus ACMI FDA UDI
- Generic Name
- Pneumatic lithotripsy system handpiece FDA UDI
- Device Name
- 9 French Electrohydraulic Lithotriptor Probe FDA UDI
- Model / Reference
- E4-9F FDA UDI
- Description
- 9 French Electrohydraulic Lithotriptor Probe FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821925040236 FDA UDI
- FDA Product Code
- FFK FDA UDI
- GMDN Term
- Pneumatic lithotripsy system handpiece 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
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
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 |
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Manufacturer
- Manufacturer
- Gyrus Acmi, Inc.
Sources (1)
- FDA UDI 18a9f0c3-64c2-4f31-8907-347b3937f81f 34 fields · synced May 31, 2026