FDA Registration
Active
🇺🇸 United States
Non-Surgical Isolation Gowns
Reg #: 1000521459
·
FEI: 1000521459
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SIGMATEX, INC. D/B/A/ SIGMATEX-LANIER TEXTILES
- Registration Number
- 1000521459
- FEI Number
- 1000521459
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 800 Third Avenue, Ste 2303
- City
- New York
- State
- NY
- ZIP
- 10022
- Country
- US
Owner / Operator
- Firm Name
- Sigmatex, Inc. d/b/a/ Sigmatex-Lanier Textiles
- Operator Number
- 10075645
- Address
- 800 Third Avenue, Suite 2303
- City
- New York
- State
- NY
- Postal Code
- 10022
- Country
- US
- Correspondent
- Marcia Rodriguez
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2020-06-22 |
Proprietary Names
Non-Surgical Isolation Gowns
Establishment Types
Complaint File Establishment per 21 CFR 820.198