FDA.report

T-Handle Folding Cane

Primary DI
00616784013510
Brand
T-Handle Folding Cane
Company
DYNAREX CORPORATION
Model
10135
Published
2019-09-30
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
IPSCane

Product Code Classifications

CodeDeviceSpecialtyClass
IPSCanePhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784013510PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784013510006167840135106167840135100616784013510

GMDN Terms

TermDefinition
Single-base walking stickA rod, typically made of wood or metal, with one leg/foot and a handgrip or curved handle and without forearm support used to assist a person with a disability to maintain their balance and support their weight while walking. It may be of fixed or adjustable length, and collapsible or non-collapsible.

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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