Identity
- Trade Name
- Gyrus ACMI FDA UDI
- Generic Name
- Light source adaptor FDA UDI
- Device Name
- OLYMPUS LIGHT SRC ADAPTOR FDA UDI
- Model / Reference
- 230640 FDA UDI
- Description
- OLYMPUS LIGHT SRC ADAPTOR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821925018273 FDA UDI
- 510(k) Number
- K932988 FDA UDI
- FDA Product Code
- EOB FDA UDI
- GMDN Term
- Light source adaptor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4760 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
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 83e07b5c-74c7-44aa-86b7-e68bcb36611c 35 fields · synced Jun 1, 2026