Compliance

FDA UDI

Class II (US FDA UDI)

by Metrex Research

Identity

Trade Name: Compliance FDA UDI
Generic Name: Hydrogen peroxide device sterilant FDA UDI
Device Name: Sterilizing and Disinfecting Solution 7.35% Hydrogen Peroxide FDA UDI
Model / Reference: 10-2500 FDA UDI
Description: Sterilizing and Disinfecting Solution 7.35% Hydrogen Peroxide FDA UDI

Identifiers

Primary DI / UDI-DI: 00615375003688 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Total Volume — 1 Gallon FDA UDI

Category: Hydrogen peroxide device sterilant

Compliance by Metrex Research — 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:

SporGon — DECON LABORATORIES, INC.

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: Metrex Research

Sources (1)

FDA UDI 31f91b1b-37ce-478e-848e-99b90cf364f8 37 fields · synced May 30, 2026