Identity
- Trade Name
- Pre-Processing Sink FDA UDI
- Generic Name
- Endoscope washer/disinfector FDA UDI
- Device Name
- A device intended to flush endoscopes. FDA UDI
- Model / Reference
- 83-S8 FDA UDI
- Description
- A device intended to flush endoscopes. FDA UDI
Identifiers
- Primary DI / UDI-DI
- PPS83S8 FDA UDI
- 510(k) Number
- K162120 FDA UDI
- FDA Product Code
- FEB FDA UDI
- GMDN Term
- Endoscope washer/disinfector FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
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
Pre-Processing Sink by Wassenburg Medical, 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
- Wassenburg Medical, Inc.
Sources (1)
- FDA UDI d597d277-06fe-44fc-b2cb-b2ca3e4c1e44 37 fields · synced May 30, 2026