Identity
- Trade Name
- Prolystica FDA UDI
- Generic Name
- Medical device cleaning agent FDA UDI
- Device Name
- Prolystica High Performance Enzymatic Manual Cleaner is formulated to deliver superior performance during manual cleaning process and provides enhanced visibility of instruments by reducing cloudiness in the cleaning solution. FDA UDI
- Model / Reference
- 1C2310 FDA UDI
- Description
- Prolystica High Performance Enzymatic Manual Cleaner is formulated to deliver superior performance during manual cleaning process and provides enhanced visibility of instruments by reducing cloudiness in the cleaning solution. FDA UDI
Identifiers
- Catalog Number
- 1C2310 FDA UDI
- Primary DI / UDI-DI
- 00724995224943 FDA UDI
- FDA Product Code
- FLG FDA UDI
- GMDN Term
- Medical device cleaning agent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6150 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Medical device cleaning agent
Prolystica by Steris Corporation — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Steris Corporation
Sources (1)
- FDA UDI f5a462d6-6256-46c8-ae98-90ab71b5104c 35 fields · synced Jun 8, 2026