FDA 510(k)

Cardinal Health Sterilization Wrap

N.º K: K161910 · 2017-04-20

Fecha de decisión2017-04-20

Código de productoFRG

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Cardinal Health Sterilization Wrap is the device name listed in this FDA 510(k) record. The listed applicant is Cardinal Health200, LLC. It received FDA 510(k) clearance on 2017-04-20 under 510(k) number K161910. 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 Cardinal Health Sterilization Wrap?

Cardinal Health Sterilization Wrap is a medical device that received FDA 510(k) clearance on 2017-04-20. The listed applicant is Cardinal Health200, LLC. The 510(k) number is K161910.

When did Cardinal Health Sterilization Wrap receive FDA 510(k) clearance?

Cardinal Health Sterilization Wrap received FDA 510(k) clearance on 2017-04-20, under 510(k) number K161910.

Who is the listed applicant for Cardinal Health Sterilization Wrap?

The FDA 510(k) record lists Cardinal Health200, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cardinal Health Sterilization Wrap?

The FDA product code for Cardinal Health Sterilization Wrap is FRG.

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Otros registros que enlistan a Cardinal Health200, LLC como solicitante

K241780Cardinal Health Nitrile Exam Gloves K230838Cardinal Health™ SmartGown™ EDGE Breathable Surgical Gown with ASSIST™ Instrument Pockets K223376Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)K230028Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express Sleeves, Kendall SCD Express Foot Cuff, Kendall SCD Sequential Compression Comfort Sleeves, Kendall SCD SmartFlow Controller Tubing Assembly K201592Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove K211390Nitrile Blue Powder-free Examination Glove

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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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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.