Identity
- Trade Name
- Gyrus ACMI FDA UDI
- Generic Name
- Ear excavator FDA UDI
- Device Name
- EXCAVATOR LEFT SMALL EBONY FINISH STAINLESS STEEL FDA UDI
- Model / Reference
- 917605 FDA UDI
- Description
- EXCAVATOR LEFT SMALL EBONY FINISH STAINLESS STEEL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821925024229 FDA UDI
- FDA Product Code
- LRC FDA UDI
- GMDN Term
- Ear excavator FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4420 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
Yes
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 I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Gyrus Acmi, Inc.
Sources (1)
- FDA UDI 6827a814-8a15-4213-96ce-5036072bd4f7 34 fields · synced Jun 8, 2026