FDA 510(k)

Medline Reusable Sterilization Wrappers

N.º K: K234132 · 2024-09-17

Fecha de decisión2024-09-17

Código de productoFRG

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Medline Reusable Sterilization Wrappers is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, LP. It received FDA 510(k) clearance on 2024-09-17 under 510(k) number K234132. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Medline Reusable Sterilization Wrappers?

Medline Reusable Sterilization Wrappers is a medical device that received FDA 510(k) clearance on 2024-09-17. The listed applicant is Medline Industries, LP. The 510(k) number is K234132.

When did Medline Reusable Sterilization Wrappers receive FDA 510(k) clearance?

Medline Reusable Sterilization Wrappers received FDA 510(k) clearance on 2024-09-17, under 510(k) number K234132.

Who is the listed applicant for Medline Reusable Sterilization Wrappers?

The FDA 510(k) record lists Medline Industries, LP as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medline Reusable Sterilization Wrappers?

The FDA product code for Medline Reusable Sterilization Wrappers is FRG.

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Dispositivos relacionados (Código: FRG)

K261897HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* TechnologyO&M Halyard, Inc.K252823Dukal Crepe Paper Sterilization WrapDukal, LLC K253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization WrapO&M Halyard, Inc.K251347Sterilization Pouch/RollSterivic Medical Co., Ltd.K251177Self-Seal Sterilization Pouch and RollGuangdong Maidi Medical Co., Ltd.K250306Chex-All Sterilization Pouches and TubesPropper Manufacturing Co., Inc.

Fuente oficial

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