FDA.reportPublic FDA data

BRYDAN MEDICAL

Primary DI
00863574000445
Brand
BRYDAN MEDICAL
Company
BRYDAN MEDICAL HOLDINGS
Model
12305
Device description
Adult Walker, adj height: 32'-36' Green crossbrace
Published
2017-12-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional

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
00863574000445PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00863574000445008635740004458635740004450863574000445

GMDN Terms#

Term, Definition table
TermDefinition
Basic walker, foldableAn all- or partially-wheeled mobility aid in the form of a waist-high, foldable framework with handgrips and four or three legs designed to provide a stable support to a person with a disability, a geriatric or an infirm person when standing or ambulating; it may also be used during rehabilitation. It is constructed of lightweight metal, plastic, and rubber materials and in the form of a mobile support structure which the user holds and pushes in front of them as they walk. It is foldable for storage and transportation, and includes a braking mechanism; it may be width-adjustable and some types may include a seat on which the user can rest.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078612438
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853301008257Brydan Medical900792024-10-15
00853301008264Brydan Medical900942024-10-15
00853301008271Brydan Medical900532024-10-15
00853301008288Brydan Medical900472024-10-15
00853301008295Brydan Medical900862024-10-15
00853301008448Brydan Medical125252024-10-15
00853301008028BRYDAN MEDICAL116292018-01-03
00853301008035BRYDAN MEDICAL115272018-01-03
00853301008431BRYDAN MEDICAL900512018-01-03
00863574000452BRYDAN MEDICAL122042017-12-29
00853301008011BRYDAN MEDICAL110842017-12-30
00853301008042BRYDAN MEDICAL119452018-01-03
00853301008059BRYDAN MEDICAL118992018-01-03
00853301008066BRYDAN MEDICAL118772018-01-03
00853301008073BRYDAN MEDICAL110972018-01-03
00853301008080BRYDAN MEDICAL124322018-01-03
00853301008097BRYDAN MEDICAL900662018-01-03
00863574000438BRYDAN MEDICAL115072018-01-03
00863574000469BRYDAN MEDICAL113672017-12-30
00863574000476BRYDAN MEDICAL999992018-01-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06977176610255BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
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