FDA.report

Easy Mount™ 9 Hole Flange w/Cover (32" White)

Primary DI
10689281006733
Brand
Easy Mount™ 9 Hole Flange w/Cover (32" White)
Company
Healthcraft Products Inc.
Model
G125SW32F9
Catalog number
00673
Device description
A high quality 32" powder coat white steel grab bar that is fixed to the wall and is intended to provide a person with a disability a supportive hand-hold whilst standing and moving. This grab bar may be installed in any room of the home.
Published
2021-08-25
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
IKXAid, Transfer

Product Code Classifications

CodeDeviceSpecialtyClass
IKXAid, TransferPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10689281006733PackageGS110In Commercial Distribution
00689281006736PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1068928100673310689281006733
00689281006736006892810067366892810067360689281006736

GMDN Terms

TermDefinition
Hand railA device that is fixed to the wall and is of differing bar shaped designs that is intended to provide a person with a disability a supportive hand-hold whilst standing and moving.

Sterilization Methods

Method

Regulatory Flags

DUNS number
252468293
Device count
1
DM exempt
true
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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