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FDA 510(k)

SterileRight sterilization pouch and roll

K-Number: K212338 · 2021-11-01

ApplicantSterileright Packaging Mfg., Inc.
Decision Date2021-11-01
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Devices (Code: FRG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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, LLCK253454HALYARD* 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.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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