# Zyris, Inc. (manufacturer, Santa Barbara, CA): 3 new FDA device listings, incl. drape, surgical, exempt

**Score:** 85/100

| Field | Value |
|---|---|
| Establishment | Zyris, Inc. |
| Role | Manufacturer |
| Establishment types | Repack or Relabel Medical Device; Manufacture Medical Device |
| Location | Santa Barbara, CA, US |
| New listings | 3 |
| Devices | Drape, Surgical, Exempt; Dental Barriers And Sleeves; Evacuator, Oral Cavity |
| Product codes | PUI, PEM, EHZ |
| Device classes | Class I, Class II |
| Medical specialties | General, Plastic Surgery, Dental |
| Brand names | Barrier Sleeves; Isolite; Isolite Pro; Isovac; Isovac 2; Isolite 3; Isolite Core+; Isolite Core |
| First new listing | 2026-06-09 |
| Latest new listing | 2026-06-17 |
| FDA registration number | 2032574 |
| Registration expires | 2027-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- 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.