FDA.report

Ponseti® Lite

Primary DI
00810060880579
Brand
Ponseti® Lite
Company
MD ORTHOPAEDICS, INC.
Model
LITE SIZE 5 RW
Catalog number
LITE SIZE 5 RW
Device description
Lite Size 5 Right Gray
Published
2023-11-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
KNPOrthosis, Corrective Shoe

Product Code Classifications

CodeDeviceSpecialtyClass
KNPOrthosis, Corrective ShoePhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810060880579PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810060880579008100608805798100608805790810060880579

GMDN Terms

TermDefinition
Ankle/foot orthosisA prefabricated (non-customized) externally applied and wearable appliance or apparatus intended to encompass the ankle joint, or the ankle and foot, to support, align, prevent, or correct orthopaedic deformities/injuries or to improve function of the ankle and/or foot through actions such as alignment, hinge-support, or dorsiflexion assistance. It may also be intended to offload and redistribute foot pressures that affect pedal circulation to improve blood flow and help heal diabetic foot ulcers or postsurgical wounds, and may include patient adaptable plantar inserts. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
146220269
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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00810060888209Rhino Leg Strap Blue - Preemie273602024-01-02
00810060888216Rhino Leg Strap Blue - Extra Small273612024-01-02

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