Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004967086

FEI Number

3004967086

Entity Name

Ortho Pauher Ind. Com. E Dist. Ltda

City/State/Country

Recife Pernambuco, BR

Establishment Address

R. Bandeirante, 94, Afogados, Recife Pernambuco 50770-460, BR

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device,Foreign Private Label Distributor

Owner / Operator

ORTHO PAUHER (Owner Number: 10032389)

Owner / Operator Contact Address

R. Bandeirante, 94, Afogados, Recife, BR-PE 50770-460, BR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NOJ	Prosthesis, Breast, External, No Adhesive	General, Plastic Surgery	Class 1	878.3800	2010-05-19
KNO	Accessories, Wheelchair	Physical Medicine	Class 1	890.3910	2010-05-19
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2010-05-19
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2010-05-19
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2010-05-19
ILG	Stocking, Elastic	Physical Medicine	Class 1	890.3475	2010-05-19
KIA	Cover, Cast	General Hospital	Class 1	880.6185	2010-05-19
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2010-05-19
FHA	Clamp, Penile	Gastroenterology, Urology	Class 1	876.5160	2010-05-19
KNP	Orthosis, Corrective Shoe	Physical Medicine	Class 1	890.3475	2010-05-08
IPT	Orthosis, Thoracic	Physical Medicine	Class 1	890.3490	2021-02-10
IOD	Components, Exercise	Physical Medicine	Class 1	890.5350	2010-05-19
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2010-05-19

Official Correspondent

No official correspondent registered.

US Agent Details

Jay Mansour Business: Mansour Consulting LLC Email: jay@mansourconsulting.com Phone: (678) 9088180

Related Public Records

Same Entity

ORTHO PAUHER

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004967086. Last updated year: 2026. Please use registration number 3004967086 when referencing this establishment in official correspondence.