← Product Code [FRG](/productcode/FRG) · K261897

# HALYARD* 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* Technology (K261897)

_O&M Halyard, Inc. · FRG · Jul 2, 2026 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K261897

## Device Facts

- **Applicant:** O&M Halyard, Inc.
- **Product Code:** [FRG](/productcode/FRG.md)
- **Decision Date:** Jul 2, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.6850
- **Device Class:** Class 2
- **Review Panel:** General Hospital
- **Attributes:** 3rd-Party Reviewed

## Regulatory Identification

A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

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**Source:** [https://fda.innolitics.com/device/K261897](https://fda.innolitics.com/device/K261897)

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