FDA.reportPublic FDA data

ORLIMAN

Primary DI
08435025914810
Brand
ORLIMAN
Company
ORLIMAN S.L.U.
Model
B-110#8
Published
2023-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
EXNSupport, Hernia

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EXNSupport, HerniaGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08435025914810PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08435025914810084350259148108435025914810

GMDN Terms#

Term, Definition table
TermDefinition
Abdominal hernia truss, reusableA device, typically in the form of a strap(s), designed to be worn over an abdominal hernia opening (weakness in the abdominal wall) to prevent protrusion of the abdominal contents and retain the reduced hernia within the abdominal cavity. It may be made from a variety or combination of various materials (e.g., elastic, canvas, or metallic). This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
479135550
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08435025919709ORLIMAND-111#112024-07-10
08435025922143ORLIMANI-112#102024-07-10
08435025922150ORLIMANI-112#112024-07-10
08435025914827ORLIMANB-110#92023-08-01
08435025914834ORLIMANB-110#102023-08-01
08435025914841ORLIMANB-110#112023-08-01
08435025914858ORLIMANB-110#122023-08-01
08435025919679ORLIMAND-111#82023-08-01
08435025919686ORLIMAND-111#92023-08-01
08435025919693ORLIMAND-111#102023-08-01
08435025922129ORLIMANI-112#82023-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08435025919709ORLIMANORLIMAN S.L.U.EXN2024-07-10
08435025922143ORLIMANORLIMAN S.L.U.EXN2024-07-10
08435025922150ORLIMANORLIMAN S.L.U.EXN2024-07-10
05391512282905HPH Corp.INDACO SRLEXN2024-04-04
05391512282912HPH Corp.INDACO SRLEXN2024-04-04
05391512282929HPH Corp.INDACO SRLEXN2024-04-04
05391512282936HPH Corp.INDACO SRLEXN2024-04-04
05391512282943HPH Corp.INDACO SRLEXN2024-04-04
05391512282950HPH Corp.INDACO SRLEXN2024-04-04
05391512282967HPH Corp.INDACO SRLEXN2024-04-04
05391512282974HPH Corp.INDACO SRLEXN2024-04-04
05391512282981HPH Corp.INDACO SRLEXN2024-04-04
05391512282998HPH Corp.INDACO SRLEXN2024-04-04
05391512283001HPH Corp.INDACO SRLEXN2024-04-04
05391512283018HPH Corp.INDACO SRLEXN2024-04-04
05391512283025HPH Corp.INDACO SRLEXN2024-04-04
05391512283032HPH Corp.INDACO SRLEXN2024-04-04
05391512283049HPH Corp.INDACO SRLEXN2024-04-04
05391512283056HPH Corp.INDACO SRLEXN2024-04-04
05391512283087HPH Corp.INDACO SRLEXN2024-04-04
05391512283094HPH Corp.INDACO SRLEXN2024-04-04
05391512283100HPH Corp.INDACO SRLEXN2024-04-04
05391512283117HPH Corp.INDACO SRLEXN2024-04-04
05391512283124HPH Corp.INDACO SRLEXN2024-04-04
05391512283131HPH Corp.INDACO SRLEXN2024-04-04
05391512283148HPH Corp.INDACO SRLEXN2024-04-04
05391512283155HPH Corp.INDACO SRLEXN2024-04-04
05391512283162HPH Corp.INDACO SRLEXN2024-04-04
05391512283179HPH Corp.INDACO SRLEXN2024-04-04
05391512283186HPH Corp.INDACO SRLEXN2024-04-04