FDA.reportPublic FDA data

Push braces

Primary DI
08715669002983
Brand
Push braces
Company
Nea International B.V.
Model
1.10.1.13
Device description
Push care Wrist Brace L3
Published
2022-11-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IQIORTHOSIS, LIMB BRACE
PCTProstate immobilizer rectal balloon

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQIOrthosis, Limb BracePhysical Medicine1
PCTProstate Immobilizer Rectal BalloonRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08715669002983PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08715669002983087156690029838715669002983

GMDN Terms#

Term, Definition table
TermDefinition
Wrist orthosisA prefabricated (non-customized) externally applied orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or to improve function of the wrist. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+31205113888cs@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

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810178883127ViveVIVE HEALTH LLCIQI2026-07-21
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00810178883141ViveVIVE HEALTH LLCIQI2026-07-21
00810178883158ViveVIVE HEALTH LLCIQI2026-07-21
00400000326986MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000326993MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
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00400000327020MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327037MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327044MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327051MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327068MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
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00400000327082MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
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