FDA 510(k)

SterileRight sterilization pouch and roll

Número K: K212338 · 2021-11-01

RequerenteSterileright Packaging Mfg., Inc.

Data da decisão2021-11-01

Código do produtoFRG

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

SterileRight sterilization pouch and roll is the device name listed in this FDA 510(k) record. The listed applicant is Sterileright Packaging Mfg., Inc.. It received FDA 510(k) clearance on 2021-11-01 under 510(k) number K212338. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SterileRight sterilization pouch and roll?

SterileRight sterilization pouch and roll is a medical device that received FDA 510(k) clearance on 2021-11-01. The listed applicant is Sterileright Packaging Mfg., Inc.. The 510(k) number is K212338.

When did SterileRight sterilization pouch and roll receive FDA 510(k) clearance?

SterileRight sterilization pouch and roll received FDA 510(k) clearance on 2021-11-01, under 510(k) number K212338.

Who is the listed applicant for SterileRight sterilization pouch and roll?

The FDA 510(k) record lists Sterileright Packaging Mfg., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SterileRight sterilization pouch and roll?

The FDA product code for SterileRight sterilization pouch and roll 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.

Fonte oficial

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