Identity
- Trade Name
- SYSTEM 83 PLUS FDA UDI
- Generic Name
- Endoscope washer-disinfector (chemical) FDA UDI
- Device Name
- A device to disinfect endoscopes FDA UDI
- Model / Reference
- SYSTEM 83 PLUS 9 FDA UDI
- Description
- A device to disinfect endoscopes FDA UDI
Identifiers
- Primary DI / UDI-DI
- G434SYSTEM83PLUS9 FDA UDI
- FDA Product Code
- FEB FDA UDI
- GMDN Term
- Endoscope washer-disinfector (chemical) 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: Endoscope washer-disinfector (chemical)
System 83 Plus by Wassenburg Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscope washer-disinfector (chemical).
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- enspire — Corporation Steris Canada · Class II
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- ENDOSCOPE REPROCESSOR — Olympus Medical Systems Corporation · Class II
- enspire — Corporation Steris Canada · Class II
- enspire — Corporation Steris Canada · Class II
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 ac609965-5f79-484b-86c2-50f0b5cdc539 35 fields · synced May 31, 2026