FDA Registration
Active
🇺🇸 United States
PRESTIGE AMERITECH
Reg #: 3005022483
·
FEI: 3005022483
·
Expires 2026
Products
13
Proprietary Names
8
Establishment Types
4
Classifications
13
Registration Details
- Registration Name
- PRESTIGE AMERITECH
- Registration Number
- 3005022483
- FEI Number
- 3005022483
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 7201 Iron Horse Blvd.
- City
- North Richland Hills
- State
- TX
- ZIP
- 76180
- Country
- US
Regulatory Submissions
- 510(k) Number
- K220118
Owner / Operator
- Firm Name
- PRESTIGE AMERITECH
- Operator Number
- 9070341
- Address
- 7201 Iron Horse Blvd., --
- City
- North Richland Hills
- State
- TX
- Postal Code
- 76180
- Country
- US
- Correspondent
- DAN - REESE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Holder, Ureteral Catheter | EYJ | Class 1 | Gastroenterology, Urology | No | 2014-10-28 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2024-10-24 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2024-10-24 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2016-06-21 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2009-01-12 |
| Surgeon'S Gloves | KGO | Class 1 | General, Plastic Surgery | No | 2024-10-24 |
| Pediatric/Child Facemask | OXZ | Class 2 | General, Plastic Surgery | No | 2016-10-25 |
| Shield, Protective, Personnel | KPY | Class 1 | Radiology | No | 2022-08-23 |
| Respirator, Surgical | MSH | Class 2 | General, Plastic Surgery | No | 2010-12-06 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2020-11-04 |
| Surgical Mask With Antimicrobial/Antiviral Agent | OUK | Class 2 | General, Plastic Surgery | No | 2024-10-18 |
| Gown, Examination | FME | Class 1 | General Hospital | No | 2015-01-13 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2020-12-23 |
Proprietary Names
SafeSecure
Pro Gear Face Shields
Prestige Ameritech Pediatric/Child's Face Mask
ProGear
Pro Gear N95 Particulate Filter Respirator and Surgical Mask
PRESTIGE AMERITECH FACE MASK
Pro Gear Face Mask
Dry Shield Fluid Resistant Personal Protection Gown
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198