FDA.reportPublic FDA data

Medegen Medical Products, LLC

Primary DI
00700812013075
Brand
Medegen Medical Products, LLC
Company
MEDEGEN MEDICAL PRODUCTS, LLC
Model
WLK1001
Device description
Walker: Folding 1-Button 32-36in 4/Cs
Published
2020-09-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
ITJWALKER, MECHANICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITJWalker, MechanicalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00700812013075PrimaryGS10
10700812013072Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00700812013075007008120130757008120130750700812013075
1070081201307210700812013072

GMDN Terms#

Term, Definition table
TermDefinition
Walking aid handgripA device designed to help a person using a walking aid to grasp the walking aid (e.g., a walking stick, cane, crutch, walking frame or rollator) securely. Included are adjustable grips, grips with antislip material and grips of special material such as foam. This is a reusable device.

Regulatory Flags#

DUNS number
055527753
Device count
4
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00700812001201Medegen MedicalH140-01H140-012020-05-18
00700812001218Medegen Medical ProductsH140CR-01H140CR-012020-05-18
00700812001225Medegen Medical ProductsH140D-01H140D-012020-05-18
00700812001232Medegen Medical ProductsH141-01H141-012020-05-18
00700812001263Medegen Medical Products, LLCH149-012020-12-20
00700812003892Medegen Medical Products, LLC25652020-12-20
H3621580Medegen Medical products1581582016-09-23
H362158TY0Medegen Medical products158TY158TY2016-09-23
H362158V0Medegen Medical products158V158V2016-09-23
H3621780Medegen Medical products1781782016-09-23
H362178TY0Medegen Medical products178TY178TY2016-09-23
H362178V0Medegen Medical products178V178V2016-09-23
H3621800Medegen Medical products1801802016-09-23
H362180S0Medegen Medical products180S180S2016-09-23
H362180TY0Medegen Medical products180TY180TY2016-09-23
H362180V0Medegen Medical products180V180V2016-09-23
H3621820Medegen Medical products1821822016-09-23
H362182S0Medegen Medical products182S182S2016-09-23
H362182TY0Medegen Medical products182TY182TY2016-09-23
H362182V0Medegen Medical products182V182V2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06977176610248BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610255BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610262BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610279BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610286BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610293BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610309BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610316BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610323BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610330BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610347BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610354BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610361BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610378BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610385BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610392BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610408BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610415BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610422BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610439BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610446BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610453BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610460BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610477BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610484BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610491BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610507BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610514BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610521BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610538BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25