Identity
- Trade Name
- Gyrus ACMI FDA UDI
- Generic Name
- Surgical instrument maintenance lubricant FDA UDI
- Device Name
- Endoscopic Instrument Lubricant (3/PK) FDA UDI
- Model / Reference
- AE-1 FDA UDI
- Description
- Endoscopic Instrument Lubricant (3/PK) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821925038110 FDA UDI
- 510(k) Number
- K883819 FDA UDI
- FDA Product Code
- CCW FDA UDI
- GMDN Term
- Surgical instrument maintenance lubricant FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5540 FDA UDI
- Commercial Distribution
- 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
Category: Surgical instrument maintenance lubricant
Gyrus ACMI by Gyrus Acmi, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
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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 e24ed179-d3c1-4244-9515-c550947da76c 34 fields · synced May 30, 2026