FDA.report

DARCO® Body Armor® Heel Reliever

Primary DI
24251853900010
Brand
DARCO® Body Armor® Heel Reliever
Company
DARCO INTERNATIONAL, INC.
Model
BAHR-N
Catalog number
BAHR-N
Device description
Normal Grey/Blue Convoluted
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
24251853900010PackageGS112In Commercial Distribution
04251853900016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
2425185390001024251853900010
04251853900016042518539000164251853900016

GMDN Terms

TermDefinition
Lower-limb orthosis ankle/foot componentA non-powered prefabricated (non-customized) component of an externally applied and wearable lower-limb appliance or apparatus intended to encompass the ankle joint, or the ankle and foot, to support, align, prevent, or correct deformities/injuries (e.g., paralysis) or to improve function of the ankle and/or foot through actions such as alignment, hinge-support, or dorsiflexion assistance. It is intended to provide motion control functionality through a media-free mechanical resistance mechanism [i.e., spring-actuation with no fluid or gas operating media]. 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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