Identity
- Trade Name
- SPOROX® II FDA UDI
- Generic Name
- Hydrogen peroxide device sterilant FDA UDI
- Device Name
- Sporox® II Sterilizing & Disinfecting Solution 1 Gallon (3.8L) FDA UDI
- Model / Reference
- 75156 FDA UDI
- Description
- Sporox® II Sterilizing & Disinfecting Solution 1 Gallon (3.8L) FDA UDI
Identifiers
- Primary DI / UDI-DI
- D687751561 FDA UDI
- FDA Product Code
- MED FDA UDI
- GMDN Term
- Hydrogen peroxide device sterilant 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 1 Gallon FDA UDI
Category: Hydrogen peroxide device sterilant
Sporox® Ii by Sultan Healthcare Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hydrogen peroxide device sterilant.
- Liquid Ultra — CROSSTEX INTERNATIONAL, INC. · Class I
- Sterling Medical Products — APOLLO MEDICAL PRODUCTS CORP.
- Sterrad — ADVANCED STERILIZATION PRODUCTS SERVICES INC. · Class II
- 125-280 Solution™ for STERIZONE VP4 Sterilizer — Tso3, Inc. · Class II
- VAPROX — STERIS CORPORATION · Class II
- Sterrad — ADVANCED STERILIZATION PRODUCTS SERVICES INC. · Class II
- VAPROX — STERIS CORPORATION · Class II
- Sterrad — ADVANCED STERILIZATION PRODUCTS SERVICES INC. · 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
- Sultan Healthcare Inc
Sources (1)
- FDA UDI 2a5e727d-cf51-4508-bde4-5073281de4f3 36 fields · synced May 30, 2026