FDA.report

Wheelchair Lap Hugger

Primary DI
00616784303017
Brand
Wheelchair Lap Hugger
Company
DYNAREX CORPORATION
Model
13030
Published
2021-02-17
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
FRODressing, Wound, Drug
KNOAccessories, Wheelchair

Product Code Classifications

CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU
KNOAccessories, WheelchairPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784303024PackageGS110In Commercial Distribution
00616784303031PackageGS110In Commercial Distribution
00616784303048PackageGS16In Commercial Distribution
00616784303017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784303024006167843030246167843030240616784303024
00616784303031006167843030316167843030310616784303031
00616784303048006167843030486167843030480616784303048
00616784303017006167843030176167843030170616784303017

GMDN Terms

TermDefinition
Wheelchair lap trayA device designed as a flat or shallow board or vessel that is attached to a wheelchair and placed across the lap of the occupant to serve as a platform for the performance of routine activities (e.g., eating, working or carrying objects).

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
false
Sterilization required before use
false

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