FDA.report

Raised Toilet Seat with Arms

Primary DI
00616784036014
Brand
Raised Toilet Seat with Arms
Company
DYNAREX CORPORATION
Model
10360
Published
2019-11-25
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
ILSAdaptor, Hygiene

Product Code Classifications

CodeDeviceSpecialtyClass
ILSAdaptor, HygienePhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784036014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784036014006167840360146167840360140616784036014

GMDN Terms

TermDefinition
Raised toilet seatA non-powered seat designed to enable a person with a disability to sit on the toilet at an elevation above the conventional range for easier sitting and standing. It may be intended to attach to a standard toilet bowl or may be freestanding; it might also include armrests/bars to assist transfer.

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
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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