Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2032574

FEI Number

3003706371

Entity Name

ZYRIS, INC.

City/State/Country

Santa Barbara, CA, US

Establishment Address

6868A Cortona Dr, Santa Barbara, CA 93117, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Zyris, Inc. (Owner Number: 9050190)

Owner / Operator Contact Address

6868A Cortona Drive, --, Santa Barbara, CA 93117, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Barrier Sleeves Isovac Isolite Isolite 3 Isolite Core+ Isovac 2 Isolite Core Isolite Pro ISODRY ISOLITE Isovac Isolite Anterior Isolation System Operating Room Adapter (ORA) Zyris Lip Retractor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2026-06-17
PEM	Dental Barriers And Sleeves	General, Plastic Surgery	Class 2	878.4370	2026-06-17
EHZ	Evacuator, Oral Cavity	Dental	Class 1	872.6640	2026-06-09
EIF	Accessories, Retractor, Dental	Dental	Class 1	872.4565	2013-03-25

Official Correspondent

SANDRA HIRSCH

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Zyris, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3043535425	K-ONE MEDITECH SDN. BHD.	Sekinchan Selangor, MY
3012508471	P3 MEDICAL LTD	Bristol Bristol, City of, GB
3004133257	AMMAR APPAREL II S. DE R.L DE C.V.	CALKINI Campeche, MX
3010202439	Karl Storz Endoscopy-America, Inc.	El Segundo, CA, US
3019798849	EXCELLENT MEDICAL TECHNOLOGY (THAILAND) CO., LTD.	U-Thai District Phra Nakhon Si Ayutthaya, TH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2032574. Last updated year: 2026. Please use registration number 2032574 when referencing this establishment in official correspondence.