Identity
- Trade Name
- Gyrus ACMI FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Device Name
- ACMI For Flexible Endoscopes Soak Disinfection FDA UDI
- Model / Reference
- ENDO-ST FDA UDI
- Description
- ACMI For Flexible Endoscopes Soak Disinfection FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821925002746 FDA UDI
- 510(k) Number
- K012105 FDA UDI
- FDA Product Code
- KCT FDA UDI
- GMDN Term
- Device sterilization/disinfection container, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6850 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: Device sterilization/disinfection container, reusable
Gyrus ACMI by Gyrus Acmi, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K012105 also covers:
- Gyrus ACMI — Gyrus Acmi, Inc.
- Gyrus ACMI — Gyrus Acmi, Inc.
- SlimLine — Gyrus Acmi, Inc.
- Integra® Miltex® — Integra LifeSciences Production Corporation
- Integra® Miltex® — Integra LifeSciences Production Corporation
- Integra® Miltex® — Integra LifeSciences Production Corporation
- Integra® Miltex® — Integra LifeSciences Production Corporation
- DYONICS — Smith & Nephew, Inc.
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 92fcc7b6-b9cb-4b01-af1c-1ad29f06330e 34 fields · synced May 30, 2026