FDA.reportPublic FDA data

MEDI

Primary DI
00636257204900
Brand
MEDI
Company
MEDI MANUFACTURING, INC.
Model
DP3AU73
Device description
!DO ABDOMINAL BINDER WHITE LARGE
Published
2025-06-24
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
00636257204900PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00636257204900006362572049006362572049000636257204900

GMDN Terms#

Term, Definition table
TermDefinition
Lumbar spine orthosisA prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to encompass the lumbar spine region of the trunk to support or immobilize deformities, fractures, sprains, or strains of the spine. This is a reusable 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
00400000326986MEDISTS04352026-07-20
00400000326993MEDISTS04372026-07-20
00400000327006MEDISTS04392026-07-20
00400000327013MEDISTS04412026-07-20
00400000327020MEDISTS04432026-07-20
00400000327037MEDISTS04452026-07-20
00400000327044MEDISTS04472026-07-20
00400000327051MEDISTS05352026-07-20
00400000327068MEDISTS05372026-07-20
00400000327075MEDISTS05392026-07-20
00400000327082MEDISTS05412026-07-20
00400000327099MEDISTS05432026-07-20
00400000327105MEDISTS05452026-07-20
00400000327112MEDISTS05472026-07-20
00400000327129MEDISTS06352026-07-20
00400000327136MEDISTS06362026-07-20
00400000327143MEDISTS06372026-07-20
00400000327150MEDISTS06382026-07-20
00400000327167MEDISTS06392026-07-20
00400000327174MEDISTS06402026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00843776102321Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776102338Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776102345Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776102352Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776102369Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776102376Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776103366Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776103373Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776103380Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776103397Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776103403Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776103410Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776106046Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776106053Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776106060Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776106077Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776106084Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776106091Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776106107Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776106114Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776106121Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776106138Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776106145Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776106152Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776106169Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776106176Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776106244Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776106251Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776106268Neotech CareNEOTECH CARE INC.IQE2026-07-23
00843776106275Neotech CareNEOTECH CARE INC.IQE2026-07-23