Sporox®

FDA UDI

Class II (US FDA UDI)

by Sultan Healthcare Inc

Identity

Trade Name: SPOROX® FDA UDI
Generic Name: Hydrogen peroxide device sterilant FDA UDI
Device Name: Sporox® Test Vials - Contains: 30 test vials, 1 bottle of indicator solution, 1 solution dropper, 30 replacement tips FDA UDI
Model / Reference: 75195 FDA UDI
Description: Sporox® Test Vials - Contains: 30 test vials, 1 bottle of indicator solution, 1 solution dropper, 30 replacement tips FDA UDI

Identifiers

Primary DI / UDI-DI: D687751951 FDA UDI
FDA Product Code: JOJ FDA UDI
MED FDA UDI
GMDN Term: Hydrogen peroxide device sterilant FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.2800 FDA UDI
880.6885 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Hydrogen peroxide device sterilant

Sporox® 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.

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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 733726d5-7623-4f23-a8b7-3fa09bd0c0f0 35 fields · synced May 30, 2026