FDA.reportPublic FDA data

BRYDAN MEDICAL

Primary DI
00853301008431
Brand
BRYDAN MEDICAL
Company
BRYDAN MEDICAL HOLDINGS
Model
90051
Device description
"2"" Solid seat cushion, w/drop hooks for 26"" width chair, Forest. Green"
Published
2018-01-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional

Product Codes#

Code, Name table
CodeName
IMPCushion, Wheelchair

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMPCushion, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853301008431PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853301008431008533010084318533010084310853301008431

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair cushionA padded device designed to provide support, comfort, and assistance to the occupant of a wheelchair. It may be used to improve posture, provide back and/or side support, compensate for seat height, relieve stress points, and provide pressure alleviation for the buttocks, lumbar region, and the legs, and/or to provide an antislip mechanism. The device is typically situated behind the lower lumbar region of the back or under the buttocks and/or legs while the occupant is seated. This is a reusable device.

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
00863574000445BRYDAN MEDICAL123052017-12-29
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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