Identity
- Trade Name
- Acu-SinQ FDA UDI
- Generic Name
- Surgical instrument washer/disinfector (chemical/thermal) FDA UDI
- Device Name
- The Acu-SinQ Complete Endoscope Cleaning Aid System is designed to provide support for automated leak testing, dosing, temperature monitoring, channel flushing, rinsing, and process documentation. FDA UDI
- Model / Reference
- Acu-SinQ Complete FDA UDI
- Description
- The Acu-SinQ Complete Endoscope Cleaning Aid System is designed to provide support for automated leak testing, dosing, temperature monitoring, channel flushing, rinsing, and process documentation. FDA UDI
Identifiers
- Catalog Number
- AQSCOMP FDA UDI
- Primary DI / UDI-DI
- 00724995167745 FDA UDI
- 510(k) Number
- K181865 FDA UDI
- FDA Product Code
- FEB FDA UDI
- GMDN Term
- Surgical instrument washer/disinfector (chemical/thermal) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical instrument washer/disinfector (chemical/thermal)
Acu-SinQ by Corporation Steris Canada — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Corporation Steris Canada
Sources (1)
- FDA UDI add77ea6-7bc8-400e-b913-c0ce00af6263 36 fields · synced May 29, 2026