Identity
- Trade Name
- TD-12® FDA UDI
- Generic Name
- Medical device disinfection agent FDA UDI
- Device Name
- PAA High-Level Disinfectant FDA UDI
- Model / Reference
- TD-12 FDA UDI
- Description
- PAA High-Level Disinfectant FDA UDI
Identifiers
- Catalog Number
- CS-TD-12 FDA UDI
- Primary DI / UDI-DI
- B205CSTD121 FDA UDI
- 510(k) Number
- K192228 FDA UDI
- FDA Product Code
- MED FDA UDI
- GMDN Term
- Medical device disinfection agent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6885 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Medical device disinfection agent
Td-12® by Cs Medical Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K192228 also covers:
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
- Cs Medical Llc
Sources (1)
- FDA UDI f1718967-e62a-4e8e-bbd5-e0be61689bfb 36 fields · synced May 29, 2026