FDA.reportPublic FDA data

M-Brace Air

Primary DI
05391512282240
Brand
M-Brace Air
Company
INDACO SRL
Model
0T6 Left
Catalog number
Hernia Pad
Device description
Our Hernia pads are available in Left and Right.Product details: 100% Cotton on the skin, Washable, Breathable, Non-Allergenic, Grey colorThey are included in our Hernia Support Brief Products # 610, 609, 648, 655, 672.They can be purchased separately if needed.
Published
2024-02-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true

Contact Domains#

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
05391512282240PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391512282240053915122822405391512282240

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

Contacts#

Phone, Email table
PhoneEmail
866-374-4050contact@m-brace.com

Regulatory Flags#

DUNS number
338470646
Device count
1
Premarket exempt
true
Combination product
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391512281021M-Brace Air576 S5762024-02-15
05391512281038M-Brace Air576 M5762024-02-15
05391512281045M-Brace Air576 L5762024-02-15
05391512281052M-Brace Air576 XL5762024-02-15
05391512281441M-Brace Air576 XXL5762024-02-15
05391512282905HPH Corp.648K size 26648K2024-04-04
05391512282912HPH Corp.648K size 28648K2024-04-04
05391512282929HPH Corp.648K size 30648K2024-04-04
05391512282936HPH Corp.648K size 32648K2024-04-04
05391512282943HPH Corp.648K size 34648K2024-04-04
05391512282950HPH Corp.648K size 36648K2024-04-04
05391512282967HPH Corp.648K size 38648K2024-04-04
05391512282974HPH Corp.648K size 40648K2024-04-04
05391512282981HPH Corp.648K size 42648K2024-04-04
05391512282998HPH Corp.648K size 44648K2024-04-04
05391512283001HPH Corp.648K size 46648K2024-04-04
05391512283018HPH Corp.648K size 48648K2024-04-04
05391512283025HPH Corp.648K size 50648K2024-04-04
05391512283032HPH Corp.648K size 52648K2024-04-04
05391512283049HPH Corp.648K size 54648K2024-04-04

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