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STERITEC PRODUCT MFG. CO., INC.

Last updated May 30, 2026

What STERITEC PRODUCT MFG. CO., INC. makes

The company manufactures chemical and biological indicators used to verify sterilization processes, including steam, ethylene oxide, and chemical sterilization. It also produces single-use sterilization packaging, such as tapes and pouches, as well as non-antimicrobial surgical and medical respirators. Additional products include sterilization integrators and test packs for monitoring sterilization cycles, such as Bowie-Dick tests.

These devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States, adhering to applicable U.S. medical device compliance requirements.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does SteriTec Product Mfg. Co., Inc. manufacture?

The company specializes in products for monitoring and packaging sterilization processes. Their portfolio includes chemical and biological sterilization indicators, sterilization integrators, Bowie-Dick test packs, and sterilization packaging tapes and pouches. Additionally, they manufacture non-antimicrobial, single-use surgical and medical respirators. This range of products is designed to verify the effectiveness of sterilization cycles and support clinical safety.

Where is SteriTec Product Mfg. Co., Inc. based?

SteriTec Product Mfg. Co., Inc. is based in the United States. As a U.S.-based manufacturer, the company operates in accordance with applicable U.S. medical device compliance requirements for the production and distribution of their sterilization and respiratory equipment.

How are the devices from SteriTec Product Mfg. Co., Inc. classified and where can I find them?

The devices produced by this manufacturer are classified as Class II medical devices under FDA regulations. You can verify the presence of these products in the FDA’s Unique Device Identifier (UDI) database, which serves as the official registry for identifying medical devices throughout their distribution and use.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: —
Website: crosstex.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(888)276-7783
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 622223196

Catalogue (83)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
Getinge Assure Chemisix Sterilization Emulator	61301606200	FDA UDI	Class II	Active
SteriTec Smart-Read Steam Biological Indicator	EZSR	FDA UDI	Class II	Active
Getinge Assured Green Tape 18mm (Steam)	6001154902	FDA UDI	Class II	Unknown
SteriTec Green Card Bowie-Dick Test	BD 115	FDA UDI	Class II	Active
Getinge Pack Self-Seal Sterilization Pouch 13cm x 38cm	6005500044	FDA UDI	Class II	Unknown
SteriTec Smart-Read Steam 10^6 Biologocal Indicator	EZSR-6	FDA UDI	Class II	Active
SteriTec Emu-Graph 4	CI 144	FDA UDI	Class II	Active
Getinge Assured EO Biological Test Pack with 30 Controls	61301606710	FDA UDI	Class II	Active
Getinge Assure Green Tape 1 IN	61301606669	FDA UDI	Class II	Unknown
Getinge Assured S.M.A.R.T. Pack II Bowie-Dick Test Pack	61301605554	FDA UDI	Class II	Active
SteriTec 1" Green Tape	CI 159/1, CI 165/1	FDA UDI	Class II	Active
Getinge Assured Mini Bowie-Dick Test Pack	61301606667	FDA UDI	Class II	Active
Getinge Assure Chemisix Sterilization Emulator	61301606626	FDA UDI	Class II	Active
Getinge Steam Sterilization Integrator	61301658261, 61301600556	FDA UDI	Class II	Active
Getinge Assured Steam Sterilization Indicator	61301606813	FDA UDI	Class II	Active
SteriTec 4/10 Load Challenge Test Pack	LT 111	FDA UDI	Class II	Active
SteriTec Smart-Read Biological Test Pack with Instant Readout Integrator	BI 108	FDA UDI	Class II	Active
Getinge Assured Tape 24mm (Steam)	504053300	FDA UDI	Class II	Active
Getinge Assure AccuFast Biological Test Pack with 5 Controls	61301606638	FDA UDI	Class II	Active
SteriTec EO Gas Biological Test Pack with Instant Readout Indicator	BI 102	FDA UDI	Class II	Active
Getinge Pack Self-Seal Sterilization Pouch 15cm x 30cm	6005500046	FDA UDI	Class II	Unknown
SteriTec Integraph	CI 101	FDA UDI	Class II	Active
Getinge Pack Self-Seal Sterilization Pouch 25cm x 38cm	6005500048	FDA UDI	Class II	Unknown
SteriTec Cross-Checks EO	CI 106	FDA UDI	Class II	Active
SteriTec Instant Readout Chemical Integrator Challenge Pack	LT 101	FDA UDI	Class II	Active
Getinge Steam Integrator Strip	61301603658	FDA UDI	Class II	Active
Getinge Assured Self-Contained Biological Indicator EO	504054000, 6130160671	FDA UDI	Class II	Active
SteriTec Instant Readout Class 6 Chemical Emulator Challenge Pack	LT 108	FDA UDI	Class II	Active
Getinge Assure AccuFast Biological Test Pack with 25 Controls	61301606639	FDA UDI	Class II	Active
Getinge Blue Sterilization Indicator Tape 1"	61301600046	FDA UDI	Class II	Unknown
SteriTec Biological Test Pack with Instant Readout Integrator	BI 103	FDA UDI	Class II	Active
Getinge Assured MI Steam Migrating Integrator Strip	61301606825	FDA UDI	Class II	Active
Getinge Assured Tape 24mm (Ethylene Oxide)	504053700	FDA UDI	Class II	Active
SteriTec Green Tape 3/4"	CI 159/.75	FDA UDI	Class II	Active
Getinge Assured Tape 18mm (Ethylene Oxide)	504053600	FDA UDI	Class II	Active
Getinge Assure Chemisix Emulator Test Pack	61301606235	FDA UDI	Class II	Active
SteriTec Green Card Bowie-Dick Test Starter Kit	BD 116	FDA UDI	Class II	Active
SteriTec EO Sterilization Indicator Tape	CI 124/.75	FDA UDI	Class II	Active
Getinge Pack Self-Seal Sterilization Pouch 9cm x 13cm	6005500041	FDA UDI	Class II	Unknown
Getinge Assured Smart-Read Biological Indicator, Getinge Assured AccuFast	504054100, 61301606636, 61301606637	FDA UDI	Class II	Active
SteriTec Sterilization Tape	CI 122/.75, CI 164/.75	FDA UDI	Class II	Unknown
SteriTec EO Sterilization Indicator Tape	CI 124/1	FDA UDI	Class II	Active
SteriTec Cross-Checks S	CI 134/US	FDA UDI	Class II	Active
SteriTec Sterilization Tape - Blue	CI 123/1	FDA UDI	Class II	Unknown
Getinge Pack Self-Seal Sterilization Pouch 9cm x 23cm	6005500042	FDA UDI	Class II	Unknown
Getinge Assured Green Tape 3/4"	61301606668	FDA UDI	Class II	Active
SteriTec Steri-Pak LF Bowie-Dick Test Pack	BD 111	FDA UDI	Class II	Active
Getinge Sterilization Indicator Tape 1/2"	61301600032	FDA UDI	Class II	Active
Getinge Assured EO Biological Test Pack with 5 Controls	61301606709	FDA UDI	Class II	Active
SteriTec Chemical Indicator Test Pack for Extended Timing Cycles	LT 105	FDA UDI	Class II	Active

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