FDA.reportPublic FDA data

Elite Brite

Primary DI
06973712280388
Brand
Elite Brite
Company
Hengshui Tianjian Medical Supplies CO.,LTD
Model
universal
Published
2024-11-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ILESling, Arm, Overhead Supported

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILESling, Arm, Overhead SupportedPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973712280388PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973712280388069737122803886973712280388

GMDN Terms#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529951803
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
06973712280395HSYS2026-03-27
06973712280401HSYM2026-03-27
06973712280418HSYL2026-03-27
06973712280425HSYXL2026-03-27
06973712280104ELITE BRITEXL2024-06-03
06973712280111ELITE BRITEuniversal 2024-06-03
06973712280128ELITE BRITEuniversal 2024-06-03
06973712280135ELITE BRITEAdult universal 2024-06-03
06973712280142ELITE BRITEChild universal 2024-06-03
06973712280159ELITE BRITES Left2024-06-03
06973712280166ELITE BRITEM Left2024-06-03
06973712280173ELITE BRITEL Left2024-06-03
06973712280180ELITE BRITEXL Left2024-06-03
06973712280197ELITE BRITES Right2024-06-03
06973712280203ELITE BRITEM Right2024-06-03
06973712280210ELITE BRITEL Right2024-06-03
06973712280227ELITE BRITEXL Right2024-06-03
06973712280234ELITE BRITES Left2024-06-03
06973712280241ELITE BRITEM Left2024-06-03
06973712280258ELITE BRITEL Left2024-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810178880249ViveVIVE HEALTH LLCILE2025-07-08
00810178880256ViveVIVE HEALTH LLCILE2025-07-08
00810178880263ViveVIVE HEALTH LLCILE2025-07-08
10810178880246ViveVIVE HEALTH LLCILE2025-07-08
10810178880253ViveVIVE HEALTH LLCILE2025-07-08
10810178880260ViveVIVE HEALTH LLCILE2025-07-08
00810041980250ViveVIVE HEALTH LLCILE2024-09-06
10810041980257ViveVIVE HEALTH LLCILE2024-09-06
00810113575377ViveVIVE HEALTH LLCILE2024-06-10
00810113575384ViveVIVE HEALTH LLCILE2024-06-10
10810113575374ViveVIVE HEALTH LLCILE2024-06-10
10810113575381ViveVIVE HEALTH LLCILE2024-06-10
06973712280111ELITE BRITEHengshui Tianjian Medical Supplies CO.,LTDILE2024-06-03
06973712280296ELITE BRITEHengshui Tianjian Medical Supplies CO.,LTDILE2024-06-03
00810113573038ViveVIVE HEALTH LLCILE2023-10-18
10810113573035ViveVIVE HEALTH LLCILE2023-10-18
00818323020540VIVEVIVE HEALTH LLCILE2019-01-20
10818323020547VIVEVIVE HEALTH LLCILE2019-01-20
00818323025903VIVEVIVE HEALTH LLCILE2019-01-19
10818323025900VIVEVIVE HEALTH LLCILE2019-01-19