FDA.report

Ever-Soft Coccyx Gel Foam Cushion

Primary DI
00616784063645
Brand
Ever-Soft Coccyx Gel Foam Cushion
Company
DYNAREX CORPORATION
Model
10636
Device description
Coccyx Gel Foam Cushion 20"x16"x3"
Published
2021-04-22
Public version status
New
Distribution status
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
00616784063645PackageGS14In Commercial Distribution
00840117307506PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784063645006167840636456167840636450616784063645
00840117307506008401173075068401173075060840117307506

GMDN Terms

TermDefinition
Perineal/coccygeal cushionA soft pillow or pad that is round or oval with a hole in its centre, intended to alleviate pressure on the caudal extremity of the vertebral column (coccyx) and/or perineal area. It is used when sitting to relieve pain from hemorrhoids or during recovery from surgery, pregnancy, or injury. The device is typically made of foam or an air inflatable vinyl or rubber.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008124539
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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