Identity
- Trade Name
- Monolith InstruZyme conc. FDA UDI
- Generic Name
- Medical device cleaning agent FDA UDI
- Model / Reference
- M205 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04064896000267 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
No
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
Monolith InstruZyme conc. by Prisman Inc. — 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
- Prisman Inc.
Sources (1)
- FDA UDI b09a03c8-b354-4b9b-956c-c30668de20c1 32 fields · synced Jun 8, 2026