FDA.reportPublic FDA data

Coretech

Primary DI
00810041987884
Brand
Coretech
Company
VIVE HEALTH LLC
Model
SUP1039
Device description
916 Wrist Brace
Published
2021-11-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
ILHSplint, Hand, And Components

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILHSplint, Hand, And ComponentsPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810041987881PackageGS124In Commercial Distribution
00810041987884PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081004198788110810041987881
00810041987884008100419878848100419878840810041987884

GMDN Terms#

Term, Definition table
TermDefinition
Wrist splint, reusableA rigid external support designed to temporarily render the wrist immovable as therapy for non-displaced fractures, strains, sprains, and muscle injuries of the wrist. The rigid support typically includes a wrap which may be held in place with a fastener such as Velcro; it is available in a variety of sizes. This is a reusable device.

Regulatory Flags#

DUNS number
047025993
Device count
1
DM exempt
true
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810178889280CoreTechSUP3128BLKS2026-05-05
00810178889297CoreTechSUP3128BLKM2026-05-05
00810178889303CoreTechSUP3128BLKL2026-05-05
00810178889310CoreTechSUP3128BLKXL2026-05-05
00810178889327CoreTechSUP3128BLK2XL2026-05-05
00810226442306ViveDMD1087CUFF2026-08-25
00810226442245ViveCSH1116GRY2026-08-21
00810226442290ViveLVA3188BLK2026-08-21
00810178889648CoreTechSUP3156BLK2026-08-19
00810178889655ViveMOB1162BLK2026-08-19
00810178889662ViveMOB1162DBU2026-08-19
00810178889679ViveMOB1162TAL2026-08-19
00810226442016ViveLVA3187BLU422026-08-19
00810226442023ViveLVA3187BLU482026-08-19
00810226442030ViveLVA3187BLU542026-08-19
00810226441965ViveLVA3184BLK2026-08-14
00810226441972ViveLVA3184BLK2PAK2026-08-14
00810226441989ViveLVA3185BLK2026-08-14
00810178887743ViveRHB3076M2026-08-07
00810041980229ViveSUP1064TAL2026-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50609576700274Puritan®Puritan Medical ProductsILH2026-07-27
06974546525140TealmedNingbo Tealmed Emergency Products Co., Ltd.ILH2026-06-25
00810226440036ViveVIVE HEALTH LLCILH2026-06-03
00810226440043ViveVIVE HEALTH LLCILH2026-06-03
00057475274139BIOS LivingThermor LtdILH2023-09-18
00057475274313BIOS LivingThermor LtdILH2023-09-18
00057475210175BIOS LivingThermor LtdILH2023-09-15
00057475210182BIOS LivingThermor LtdILH2023-09-15
10680651299854HalyardO&M HALYARD, INC.ILH2023-07-31
20680651299004HalyardO&M HALYARD, INC.ILH2023-06-07
B7685810200Buxton BioMedicalBUXTON BIOMEDICAL, INC.ILH2023-05-26
00057475210441BIOS LivingThermor LtdILH2023-03-31
00057475210472BIOS LivingThermor LtdILH2023-03-31
00609271100053DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271100152DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271100251DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271100350DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271100459DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271101050DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271101159DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271101258DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271101357DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271101456DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271427006BLACK FOAM WRISTDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271427013BLACK FOAM WRISTDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271427020BLACK FOAM WRISTDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271427037BLACK FOAM WRISTDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271427044BLACK FOAM WRISTDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271427051BLACK FOAM WRISTDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271427068BLACK FOAM WRISTDARCO INTERNATIONAL, INC.ILH2023-02-08