FDA.report

Wheelchair Break Lever Extension

Primary DI
00616784027043
Brand
Wheelchair Break Lever Extension
Company
DYNAREX CORPORATION
Model
10270
Device description
Wheelchair Break Lever Extension 11 inch; 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

Related Records

Product Codes

CodeName
KNOAccessories, Wheelchair

Product Code Classifications

CodeDeviceSpecialtyClass
KNOAccessories, WheelchairPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784027043PackageGS125In Commercial Distribution
00616784027012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784027043006167840270436167840270430616784027043
00616784027012006167840270126167840270120616784027012

GMDN Terms

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

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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00616784710518Sphygmomanometer71052016-09-24
00616784710617Sphygmomanometer71062016-09-24
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00616784711423PA [SensiLance Pressure Activated Safety Lancets,Sterile71142021-05-21
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00616784709529Digital Blood Pressure Monitor70952021-01-19
00616784709628Digital Blood Monitors70962021-01-19
00616784709925Blood Pressure Kit,Sphymomanometer with Dual Head Stethoscope70992016-09-24
00616784710020Blood Pressure Kit Sphygmomanometer with Stethoscope71002016-09-24
00616784710228Disposable ECG Snap Electrodes, With Pre-Gelled AG/AGCI Sensor71022016-09-24
00840117344761Resp-O2 Closed Suction Endotracheal Catheter, 8 FR (2.6 mm)310612026-05-25
00840117344778Resp-O2 Closed Suction Endotracheal Catheter, 8 FR (2.6 mm)310622026-05-25
00840117346215Resp-O2 Closed Suction Endotracheal Catheter, 10 FR (3.3 mm)310632026-05-25
00840117349711IV Extension Sets Needle-Free Luer Lock Connector For Injection, Non-Toxic, 17"70612016-09-24
00840117349742IV Extension Sets Needle-Free Luer Lock Connector, Non-Toxic, 8" (20.3 cm)70622016-09-24
00616784706313IV Extension Sets Needle-Free Luer Lock Connector for Injection Non-Toxic70632024-03-25

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