FDA.report

Wheelchair Anti-tipper for S3, S4

Primary DI
00616784026817
Brand
Wheelchair Anti-tipper for S3, S4
Company
DYNAREX CORPORATION
Model
10268
Published
2019-11-18
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
IMRDevice, Anti-Tip, Wheelchair

Product Code Classifications

CodeDeviceSpecialtyClass
IMRDevice, Anti-Tip, WheelchairPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784026848PackageGS110In Commercial Distribution
00616784026817PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784026848006167840268486167840268480616784026848
00616784026817006167840268176167840268170616784026817

GMDN Terms

TermDefinition
Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsibleA wheeled personal mobility device that incorporates a seat-support system for a person with a disability or a person without the full capacity to walk (not bariatric) designed to be manually propelled by the user while seated in the device or by an attendant. The occupant moves the device by rotating both rear wheels. An attendant moves the device by pushing or pulling handles on the device. The device may be disassembled or folded for transport.

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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