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Stan-Pak Ent.

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Devices
20

What Stan-Pak Ent. makes

Stan-Pak Ent. manufactures a range of single-use medical textiles and accessories, including plain gauze sponges, bias stockinette, and cast padding materials like sheet wadding and Webril. Their portfolio also covers tracheostomy tape, Telfa strips, and vaginal packing, alongside items such as Kerlix fluffs and tonsil sponges. Sterilization processes for these products are documented under dosimetric release protocols. Safety pins and roller gauze are also part of their product line.

The company’s devices are regulated under FDA classifications, including Class I, Class II, and unclassified (U) products, with many authorised via the 510(k) pathway. Their products are listed in the FDA’s 510(k) database. Stan-Pak Ent. operates from the United States.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue20

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  • Guaze Sponges, Plain Ref K820107

    Active Regimes: 510(k) Registry: 510(k) Class:—

  • Bias Stockinette Ref K820141

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Sheet Wadding Cast Padding Ref K820097

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Roller Gauze Ref K820098

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Kerlix Fluffs Ref K820053

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Dosometric Release Sterilization Ref K823058

    Active Regimes: 510(k) Registry: 510(k) Class:—

  • Trach Tape Ref K820099

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Telfa Strips Ref K820056

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Vag Packing Ref K820096

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Webril Cast Padding Ref K820140

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Safety Pins Ref K820052

    Active Regimes: 510(k) Registry: 510(k) Class:—

  • Tonsil Sponges Ref K820095

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • X-Ray Guaze Sponges Ref K820106

    Active Regimes: 510(k) Registry: 510(k) Class:—

  • Combine Pad Or Abd Ref K820105

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Specialist Cast Padding Ref K820155

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Elastic Bandage Ref K820094

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Tubular Stockinette Ref K820142

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Frosted Glass Slides Ref K820100

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Sof-Rol Cast Padding Ref K820139

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Topper Sponges Ref K820108

    Active Regimes: 510(k) Registry: 510(k) Class:I

Rows 1-20 of 20

Frequently asked questions

How many devices does Stan-Pak Ent. have in the registry?

The registry currently lists 20 devices for Stan-Pak Ent.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Stan-Pak Ent.'s devices?

Among its 20 most recently registered devices, Stan-Pak Ent. has devices listed in FDA 510(k) (20 devices).

What risk classes do Stan-Pak Ent.'s devices fall under?

Among its 20 most recently registered devices, the classes recorded for Stan-Pak Ent.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Stan-Pak Ent. in the registry?

The most recently registered devices listed for Stan-Pak Ent. include GUAZE SPONGES, PLAIN, BIAS STOCKINETTE, SHEET WADDING CAST PADDING and ROLLER GAUZE.

Generated automatically from registry data and not verified by a human reviewer.