FDA.reportPublic FDA data

Wheelchair Break Lever Extension

Primary DI
00616784026947
Brand
Wheelchair Break Lever Extension
Company
DYNAREX CORPORATION
Model
10269
Device description
Wheelchair Break Lever Extension- 8in; pair
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

Product Codes#

Code, Name table
CodeName
KNOAccessories, Wheelchair

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNOAccessories, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784026947PackageGS125In Commercial Distribution
00616784026916PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784026947006167840269476167840269470616784026947
00616784026916006167840269166167840269160616784026916

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair brake extensionA metal lever with handle designed to be attached to an existing wheelchair brake lever, to improve handling/leverage for a wheelchair occupant who has difficulty operating the standard brake lever.

Sterilization Methods#

Method table
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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00840117322585Resp-O2 Oxygen Regulator CGA 540-Style, DISS Outlet, Brass-Sleeved363742026-10-23
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