Identity
- Trade Name
- Gyrus ACMI FDA UDI
- Generic Name
- Endoscope antifog solution FDA UDI
- Device Name
- Lens Cleaner FDA UDI
- Model / Reference
- LAS-B FDA UDI
- Description
- Lens Cleaner FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821925003453 FDA UDI
- 510(k) Number
- K883819 FDA UDI
- FDA Product Code
- CCW FDA UDI
- GMDN Term
- Endoscope antifog solution FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5540 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 I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K883819 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 I | Pending data |
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Manufacturer
- Manufacturer
- Gyrus Acmi, Inc.
Sources (1)
- FDA UDI 70b06858-6030-4ce5-8e53-e27962714c97 35 fields · synced Jun 1, 2026