FDA.report

Health Design Classic Post Op Shoe

Primary DI
10609271000978
Brand
Health Design Classic Post Op Shoe
Company
DARCO INTERNATIONAL, INC.
Model
HD-PO-CL8
Catalog number
HD-PO-CL8
Device description
Men's Extra-Large Black
Published
2023-02-08
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
true

Related Records

Product Codes

CodeName
KNPORTHOSIS, CORRECTIVE SHOE

Product Code Classifications

CodeDeviceSpecialtyClass
KNPOrthosis, Corrective ShoePhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10609271000978PackageGS112In Commercial Distribution
20609271000975PackageGS136In Commercial Distribution
70609271000970PackageGS16In Commercial Distribution
00609271000971PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1060927100097810609271000978
2060927100097520609271000975
7060927100097070609271000970
00609271000971006092710009716092710009710609271000971

GMDN Terms

TermDefinition
Orthotic shoe, non-customizedA prefabricated (non-customized) footwear designed as a shoe intended to support, align, prevent, and compensate for or correct deformities of the feet to help improve function and/or for post-operative therapy. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
184231298
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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