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FDA 510(k)

Halyard ONE-STEP* Sterilization Wrap

K-Number: K192147 · 2019-10-10

ApplicantOwens & Minor (O&M) Halyard, Inc.
Decision Date2019-10-10
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Halyard ONE-STEP* Sterilization Wrap is a medical device manufactured by Owens & Minor (O&M) Halyard, Inc.. It received FDA 510(k) clearance on 2019-10-10 under approval number K192147. 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 Halyard ONE-STEP* Sterilization Wrap?

Halyard ONE-STEP* Sterilization Wrap is a medical device that received FDA 510(k) clearance on 2019-10-10. It is manufactured by Owens & Minor (O&M) Halyard, Inc.. The 510(k) number is K192147.

When was Halyard ONE-STEP* Sterilization Wrap approved by the FDA?

Halyard ONE-STEP* Sterilization Wrap received FDA 510(k) clearance on 2019-10-10, under approval number K192147.

What company makes Halyard ONE-STEP* Sterilization Wrap?

Halyard ONE-STEP* Sterilization Wrap is manufactured by Owens & Minor (O&M) Halyard, Inc..

What is the FDA product code for Halyard ONE-STEP* Sterilization Wrap?

The FDA product code for Halyard ONE-STEP* Sterilization Wrap is FRG.

Other Devices by Owens & Minor (O&M) Halyard, Inc.

K214007HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap K232824FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802); FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White, Wrap Around Visor (41803); FLUIDSHIELD* 1 Surgical Mask with SO SOFT* Lining, White, (41805) K232777FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868); FLUIDSHIELD* 1 FogFree Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798) K232807Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802) K232812Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical Mask with Wraparound Visor (62114); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops (62115); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops and WrapAround Visor (62116) K232806HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388)

View all 12 devices →

Related Devices (Code: FRG)

K160595PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical IndicatorPms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti K162162Barrier Supreme Sterilization WrapperStandard Textile Co., Inc. K153540Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process IndicatorsSafe Secure Packaging Co., Ltd. K160755Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization WrapAhlstrom Nonwovens, LLC K160908Vis-U-All Low Temperature Sterilization Pouch/TubingSTERIS Corporation K152564Gemini Sterilization WrapMedline Industries, 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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