FDA.reportPublic FDA data

MEDI

Primary DI
00636257200599
Brand
MEDI
Company
MEDI MANUFACTURING, INC.
Model
LS01234
Device description
HERNIA SUPPORT BELT, SIZE XL
Published
2025-04-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IQEORTHOSIS, LUMBAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQEOrthosis, LumbarPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00636257200599PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00636257200599006362572005996362572005990636257200599

GMDN Terms#

Term, Definition table
TermDefinition
Intestinal stoma shield/support belt, single-useA non-sterile plate, typically with a waist belt for attachment, intended to be placed over an enteric stoma (surgically-created artificial opening between the intestines and the body surface through which bodily waste is drained) to protect it from harmful external influences (e.g., knocks, friction), to reduce the risk of stomal herniation, or to help maintain adhesion of the base plate to the skin. Also known as a stoma protector it is usually attached by the patient to the base plate/wafer that retains the stomal bag, or might be placed directly over the stomal opening when the bag is removed; it may in addition include an attachable ostomy bag protector. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-6334info@mediusa.com

Regulatory Flags#

DUNS number
960754430
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
00636257192283MEDI205572026-06-01
00636257214749MEDI107S512026-06-01
00636257214756MEDI107S522026-06-01
00636257214763MEDI107S532026-06-01
00636257214770MEDI107S542026-06-01
00636257214787MEDI107S552026-06-01
00636257214794MEDI107S562026-06-01
00636257214800MEDI107S572026-06-01
00636257214817MEDI108S512026-06-01
00636257214824MEDI108S522026-06-01
00636257214831MEDI108S532026-06-01
00636257214848MEDI108S542026-06-01
00636257214855MEDI108S552026-06-01
00636257214862MEDI108S562026-06-01
00636257214879MEDI108S572026-06-01
00636257214886MEDI195S512026-06-01
00636257214893MEDI195S522026-06-01
00636257214909MEDI195S532026-06-01
00636257214916MEDI195S542026-06-01
00636257214923MEDI195S552026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00843776106367Neotech CareNEOTECH CARE INC.IQE2026-07-17
00843776106374Neotech CareNEOTECH CARE INC.IQE2026-07-17
00843776100013Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776100020Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776100037Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776100044Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776100051Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776100099Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776102499Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776102505Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776102512Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776102529Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776102536Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776103007Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776103014Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776103021Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776103038Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776103045Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776105957Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776105964Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776105971Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776105988Neotech CareNEOTECH CARE INC.IQE2026-07-14
00810178882533CoreTechVIVE HEALTH LLCIQE2026-02-09
00810178884520CoreTechVIVE HEALTH LLCIQE2025-10-30
00810179882044CopperFitIdeavillage Products CorpIQE2025-10-10
00810179882099CopperFitIdeavillage Products CorpIQE2025-10-10
00810179882105CopperFitIdeavillage Products CorpIQE2025-10-10
00810113682686Tailback 27Manamed, Inc.IQE2025-09-19
00810113682693Tailback2-42Manamed, Inc.IQE2025-09-19
00810113682723Tailback2-64Manamed, Inc.IQE2025-09-19