FDA Registration
Active
🇺🇸 United States
ZYRIS, INC.
Reg #: 2032574
·
FEI: 3003706371
·
Expires 2026
Products
5
Proprietary Names
14
Establishment Types
3
Classifications
5
Registration Details
- Registration Name
- ZYRIS, INC.
- Registration Number
- 2032574
- FEI Number
- 3003706371
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 6868A Cortona Dr
- City
- Santa Barbara
- State
- CA
- ZIP
- 93117
- Country
- US
Regulatory Submissions
- 510(k) Number
- K242435
Owner / Operator
- Firm Name
- Zyris, Inc.
- Operator Number
- 9050190
- Address
- 6868A Cortona Drive, --
- City
- Santa Barbara
- State
- CA
- Postal Code
- 93117
- Country
- US
- Correspondent
- SANDRA - HIRSCH
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2026-06-17 |
| Dental Barriers And Sleeves | PEM | Class 2 | General, Plastic Surgery | No | 2026-06-17 |
| Evacuator, Oral Cavity | EHZ | Class 1 | Dental | No | 2026-06-09 |
| Accessories, Retractor, Dental | EIF | Class 1 | Dental | No | 2013-03-25 |
| Mouthpiece, Saliva Ejector | DYN | Class 1 | Dental | No | 2015-10-14 |
Proprietary Names
Barrier Sleeves
Isovac
Isolite
Isolite 3
Isolite Core+
Isovac 2
Isolite Core
Isolite Pro
ISODRY
ISOLITE
Isolite Anterior Isolation System
Operating Room Adapter (ORA)
Zyris Lip Retractor
Isolite Mouthpiece
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility