FDA.report

Supracor Stimulite Honeycomb

Primary DI
00842749100166
Brand
Supracor Stimulite Honeycomb
Company
Supracor, Inc.
Model
CLXS2016
Published
2022-07-27
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
IMPCushion, Wheelchair

Product Code Classifications

CodeDeviceSpecialtyClass
IMPCushion, WheelchairPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842749100166PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842749100166008427491001668427491001660842749100166

GMDN Terms

TermDefinition
Wheelchair seat cushionA padded device designed to provide support, comfort, and assistance to the occupant of a wheelchair typically by improving posture, providing back and/or side support, compensating for seat height, relieving stress points, and providing pressure alleviation for the buttocks, lumbar region, and the legs, and/or by providing 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

Regulatory Flags

DUNS number
118163781
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00842749108780Supracor Stimulite Honeycomb CL24212024-10-17
00842749111025Supracor Stimulite HoneycombSMRT13152024-10-17
00842749111032Supracor Stimulite Honeycomb PD16102024-10-17
00842749111049Supracor Stimulite Honeycomb PD1512S2024-10-17
00842749111056Supracor Stimulite Honeycomb SP13122024-10-17
00842749111063Supracor Stimulite Honeycomb SP13102024-10-17
00842749111070Supracor Stimulite Honeycomb SP14132024-10-17
00842749111087Supracor Stimulite Honeycomb CLXS19142024-10-17
00842749111094Supracor Stimulite Honeycomb CL16222024-10-17
00842749111100Supracor Stimulite Honeycomb PDCD13112024-10-17
00842749111117Supracor Stimulite Honeycomb CDADJ15152024-10-17
00842749111124Supracor Stimulite Honeycomb CLB24232024-10-17
00842749111131Supracor Stimulite Honeycomb PDCD10082024-10-17
00842749111148Supracor Stimulite Honeycomb CDADJXS19192024-10-17
00842749111155Supracor Stimulite Honeycomb CDADJ22202024-10-17
00842749111162Supracor Stimulite Honeycomb CDXS20142024-10-17
00842749111179Supracor Stimulite Honeycomb CLB25252024-10-17
00842749111186Supracor Stimulite Honeycomb SM1815S2024-10-17
00842749111193Supracor Stimulite Honeycomb CLXS1714S2024-10-17
00842749111209Supracor Stimulite Honeycomb SMXS1918S2024-10-17

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