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STERITEC PRODUCT MFG. CO., INC.

US

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
—
Phone
+1(888)276-7783
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
622223196

Catalogue (83)

Page 2 of 2
DeviceModel / ReferenceRegistriesClassStatus
Getinge Sterilization Indicator Tape Ethylene Oxide (EO) 61301600379
FDA UDI
Class IIActive
SteriTec EZTest EO Biological Indicator EZEO
FDA UDI
Class IIActive
Getinge Pack Self-Seal Sterilization Pouch 14cm x 28cm 6005500045
FDA UDI
Class IIActive
SteriTec 3/4" Green Tape CI 159/.75, CI 165/.75
FDA UDI
Class IIUnknown
Getinge Assured AccuView Biological Test Pack with 25 Controls 61301606715
FDA UDI
Class IIActive
Getinge Assured Control Card 61301606815
FDA UDI
Class IIActive
SteriTec Migrating Integrator CI 163
FDA UDI
Class IIActive
Getinge Pack Self-Seal Sterilization Pouch 30cm x 45cm 6005500049
FDA UDI
Class IIUnknown
SteriTec Steam Integrator X 2 CI 143
FDA UDI
Class IIActive
SteriTec Dry Heat Indicator Labels CI 113
FDA UDI
Class IIActive
SteriTec Cross-Checks CI 107/US
FDA UDI
Class IIActive
Crosstex International SCK
FDA UDI
Class IIActive
Getinge Assure Chemisix Pack Extended Timing 61301606236
FDA UDI
Class IIActive
SteriTec Green Tape 1" CI 159/1
FDA UDI
Class IIActive
SteriTec Sterilization Tape CI 122/.5, CI 164/.5
FDA UDI
Class IIUnknown
Getinge Sterilization Indicator Tape 1" 61301600034
FDA UDI
Class IIActive
Getinge Sterilization Indicator Tape 3/4" 61301600033
FDA UDI
Class IIActive
Getinge Pack Self-Seal Sterilization Pouch 10cm x 28cm 6005500043
FDA UDI
Class IIUnknown
Getinge Assure ChemiPack Integrator Test Pack 61301605836
FDA UDI
Class IIActive
Getinge Pack Self-Seal Sterilization Pouch 20cm x 41cm 6005500047
FDA UDI
Class IIUnknown
Getinge Assure Green Tape 3/4 IN 61301606668
FDA UDI
Class IIUnknown
SteriTec Cross-Checks D CI 105
FDA UDI
Class IIActive
Getinge Assured AccuView Biological Test Pack with 5 Controls 61301606714
FDA UDI
Class IIActive
Getinge Assured Green Tape 1" 61301606669
FDA UDI
Class IIActive
SteriTec Sterilization Tape CI 122/1, CI 164/1
FDA UDI
Class IIUnknown
Getinge Pack Self-Seal Sterilization Pouch 33cm x 46cm 6005500050
FDA UDI
Class IIUnknown
SteriTec EZTest Steam Biological Indicator EZS
FDA UDI
Class IIActive
Getinge Assured Tape 18mm (Steam) 504053200
FDA UDI
Class IIActive
Getinge Assured Self-Contained Biological Indicator Steam 504053900
FDA UDI
Class IIActive
Getinge Assure S.M.A.R.T. Green Sterilizer Mechanical Air Removal Test 61301606625
FDA UDI
Class IIActive
SteriTec EZTest Steam 10^6 Biological Indicator EZS-6
FDA UDI
Class IIActive
Getinge Assured Steam Sterilization Indicator 61301606814
FDA UDI
Class IIActive
Getinge Assured Green Tape 24mm (Steam) 6001154903
FDA UDI
Class IIUnknown

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