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Sterile Concepts, Inc.

United StatesFDA applicant, unverified

Devices
10

What Sterile Concepts, Inc. makes

Sterile Concepts, Inc. makes sterile procedure trays and kits for medical and dental use, including dental hygiene trays, dentist with assistant packs, radiology packs, skin staple removal trays, general and plastic surgery packs, IV start kits, laceration trays, OB/GYN packs, orthopedic packs, and suture removal trays.

These devices are classified as Class I and Class II medical devices and are listed in the FDA 510(k) registry. The company is based in the United States.

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

Catalogue10

Newest first, rows 1-10 of 10

  • Dental Hygiene Tray Ref K944139

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

  • Dentist With Assistant Pack Ref K940864

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

  • Radiology Packs Ref K952539

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

  • Skin Staple Removal Trays Ref K943046

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

  • General And Plastic Surgery Packs Ref K951478

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

  • Iv Start Kits Ref K943047

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

  • Lacerattion Tray Ref K920763

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

  • Ob/Gyn Packs Ref K951081

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

  • Orthopedic Packs Ref K951231

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

  • Suture Removal Trays Ref K943090

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

Frequently asked questions

How many devices does Sterile Concepts, Inc. have in the registry?

The registry currently lists 10 devices for Sterile Concepts, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Sterile Concepts, Inc.'s devices?

Among its 10 most recently registered devices, Sterile Concepts, Inc. has devices listed in FDA 510(k) (10 devices).

What risk classes do Sterile Concepts, Inc.'s devices fall under?

Among its 10 most recently registered devices, the classes recorded for Sterile Concepts, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Sterile Concepts, Inc. in the registry?

The most recently registered devices listed for Sterile Concepts, Inc. include DENTAL HYGIENE TRAY, DENTIST WITH ASSISTANT PACK, RADIOLOGY PACKS and SKIN STAPLE REMOVAL TRAYS.

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