Identity
- Trade Name
- V-PRO FDA UDI
- Generic Name
- Hydrogen peroxide gas sterilizer FDA UDI
- Device Name
- The V-PRO 60 Low Temperature Sterilization System with VAPROX HC Sterilant is a vaporized hydrogen peroxide Sterilizer intended for use in the terminal Sterilization of properly cleaned, rinsed and dried reusable metal and nonmetal medical devices used in Healthcare Facilities. FDA UDI
- Model / Reference
- V-PRO 60 FDA UDI
- Description
- The V-PRO 60 Low Temperature Sterilization System with VAPROX HC Sterilant is a vaporized hydrogen peroxide Sterilizer intended for use in the terminal Sterilization of properly cleaned, rinsed and dried reusable metal and nonmetal medical devices used in Healthcare Facilities. FDA UDI
Identifiers
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6860 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
V-Pro by Steris Mexico, S. de R.L. de C.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K140498 also covers:
K162413 also covers:
K172319 also covers:
K182568 also covers:
K190917 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
- Steris Mexico, S. de R.L. de C.V.
Sources (1)
- FDA UDI 90bd2953-b32c-490f-b0c7-d1a6ade9f9f1 37 fields · synced May 30, 2026