FDA Registration
Active
🇧🇷 Brazil
Ortho Pauher Ind. Com. E Dist. Ltda
Reg #: 3004967086
·
FEI: 3004967086
·
Expires 2026
Products
17
Proprietary Names
17
Establishment Types
3
Classifications
17
Registration Details
- Registration Name
- Ortho Pauher Ind. Com. E Dist. Ltda
- Registration Number
- 3004967086
- FEI Number
- 3004967086
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- R. Bandeirante, 94, Afogados
- City
- Recife Pernambuco
- Country
- BR
Owner / Operator
- Firm Name
- ORTHO PAUHER
- Operator Number
- 10032389
- Address
- R. Bandeirante, 94, Afogados
- City
- Recife
- State
- Pernambuco
- Postal Code
- 50770-460
- Country
- BR
US Agent
- Business Name
- Mansour Consulting LLC
- Contact Name
- Jay Mansour
- Address
- 845 Aronson Lake Court
- City
- Roswell
- State
- GA
- ZIP
- 30075
- Country
- US
- [email protected]
- Phone
- 678 9088180
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Breast, External, No Adhesive | NOJ | Class 1 | General, Plastic Surgery | No | 2010-05-19 |
| Accessories, Wheelchair | KNO | Class 1 | Physical Medicine | No | 2010-05-19 |
| Elastomer, Silicone, For Scar Management | MDA | Class 1 | General, Plastic Surgery | No | 2010-05-19 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2010-05-19 |
| Bandage, Cast | ITG | Class 1 | Physical Medicine | No | 2010-05-19 |
| Stocking, Elastic | ILG | Class 1 | Physical Medicine | No | 2010-05-19 |
| Cover, Cast | KIA | Class 1 | General Hospital | No | 2010-05-19 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2010-05-19 |
| Clamp, Penile | FHA | Class 1 | Gastroenterology, Urology | No | 2010-05-19 |
| Orthosis, Corrective Shoe | KNP | Class 1 | Physical Medicine | No | 2010-05-08 |
| Orthosis, Thoracic | IPT | Class 1 | Physical Medicine | No | 2021-02-10 |
| Components, Exercise | IOD | Class 1 | Physical Medicine | No | 2010-05-19 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2010-05-19 |
| Adaptor, Recreational | ILT | Class 1 | Physical Medicine | No | 2010-05-19 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2010-05-19 |
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 2020-01-21 |
| Cover, Limb | IPM | Class 1 | Physical Medicine | No | 2010-05-19 |
Proprietary Names
Breast Prothesis
Wheelchair Accesories
Silicone Scars Elastomer
Elastic Bandage
Cast Bandage
Stocking Elastic
Cast, Cover
Skin Protector
Penile, Clamp
Corrective Shoe
Ortho Pauher Orthosis For Pectus Excavatum
Exercise Componets
Rehusable Pack (Hot, Cold)
Adaptor
External Brace, Ankle
Ortho Pauher Patient Positioners
Limb Cover
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Foreign Private Label Distributor
Manufacture Medical Device