Identity
- Trade Name
- SporGon FDA UDI
- Generic Name
- Hydrogen peroxide device sterilant FDA UDI
- Device Name
- SporGon is a sterilant cleaning solution used in labs to clean surfaces, equipment and medical devices. FDA UDI
- Model / Reference
- 1 Gallon Bottle FDA UDI
- Description
- SporGon is a sterilant cleaning solution used in labs to clean surfaces, equipment and medical devices. FDA UDI
Identifiers
- Catalog Number
- 4301 FDA UDI
- Primary DI / UDI-DI
- 00864780000311 FDA UDI
- 510(k) Number
- K972708 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
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Hydrogen peroxide device sterilant
SporGon by Decon Laboratories, 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
- SPOROX® II — Sultan Healthcare Inc · Class II
- VAPROX — STERIS CORPORATION · Class II
Cleared under the same submission
K972708 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Decon Laboratories, Inc.
Sources (1)
- FDA UDI 0fa4b3ff-112a-44d7-a8dc-4314cf202b91 35 fields · synced May 31, 2026