# Halyard North Carolina, LLC (manufacturer, Linwood, NC): 2 new FDA device listings, incl. wrap, sterilization

**Score:** 70/100

| Field | Value |
|---|---|
| Establishment | Halyard North Carolina, LLC |
| Owner / operator | O&M Halyard, Inc. |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | Linwood, NC, US |
| New listings | 2 |
| Devices | Wrap, Sterilization |
| Product codes | FRG |
| Device classes | Class II |
| Medical specialties | General Hospital |
| Brand names | HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY*Technology; HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap |
| First new listing | 2026-07-07 |
| Latest new listing | 2026-07-07 |
| FDA registration number | 1054380 |
| Registration expires | 2026-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- U.S. establishment.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.