FDA.reportPublic FDA data

Push braces

Primary DI
08715669003454
Brand
Push braces
Company
Nea International B.V.
Model
3.20.1.23
Device description
Push ortho Ankle Brace Aequi R3
Published
2023-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITWJOINT, ANKLE, EXTERNAL BRACE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITWJoint, Ankle, External BracePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08715669003454PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08715669003454087156690034548715669003454

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
+31434079220cs@push.eu

Regulatory Flags#

DUNS number
410032197
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08715669003126Push braces2.10.2.112023-03-31
08715669003133Push braces2.10.2.122023-03-31
08715669003140Push braces2.10.2.132023-03-31
08715669003157Push braces2.10.2.142023-03-31
08715669003164Push braces2.10.2.212023-03-31
08715669003171Push braces2.10.2.222023-03-31
08715669003188Push braces2.10.2.232023-03-31
08715669003195Push braces2.10.2.242023-03-31
08715669008909Push Sports4.10.1.124.10.1.122023-03-31
08715669008916Push Sports4.10.1.134.10.1.132023-03-31
08715669008923Push Sports4.10.1.214.10.1.212023-03-31
08715669008930Push Sports4.10.1.224.10.1.222023-03-31
08715669008947Push Sports4.10.1.234.10.1.232023-03-31
08715669008954Push Sports4.10.2.104.10.2.102023-03-31
08715669008961Push Sports4.10.2.204.10.2.202023-03-31
08715669003041Push braces2.10.1.112023-02-20
08715669003058Push braces2.10.1.122023-02-20
08715669003065Push braces2.10.1.132023-02-20
08715669003072Push braces2.10.1.142023-02-20
08715669003089Push braces2.10.2.212023-02-20

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Primary DI, Brand, Company table
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