FDA.reportPublic FDA data

Vive

Primary DI
00810178886647
Brand
Vive
Company
VIVE HEALTH LLC
Model
LVA3130BLKR
Device description
Palm Protector with Finger Separators (Right)
Published
2026-02-09
Public version status
New
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
00810178886647PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810178886647008101788866478101788866470810178886647

GMDN Terms#

Term, Definition table
TermDefinition
Wrist/hand/metacarpophalangeal joint extension orthosisAn externally applied orthopaedic appliance or apparatus designed to assist in the extension of the wrist, hand, and metacarpophalangeal joints (MP joints or knuckles). The device has an outrigger (a projecting support) to assist in the extension of the thumb. This is a reusable device.

Sterilization Methods#

Method table
Method

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
00810226440104ViveLVA3167BLK2026-06-04
00810226440111ViveLVA3167BLKPAK22026-06-04
00810178889969ViveLVA3166WHT2026-06-03
00810178889976ViveLVA3164BBB2026-06-03
00810178889983ViveLVA3164BBP2026-06-03
00810178889990ViveLVA3164BGN2026-06-03
00810226440005ViveLVA3165BB2026-06-03
00810226440012ViveLVA3165BP2026-06-03
00810226440029ViveLVA3165GN2026-06-03
00810226440036ViveSUP3008BLU2026-06-03
00810226440043ViveSUP3008PNK2026-06-03
00810178889624Vive BreatheLVA31612026-06-01
00810178889921ViveCareRHB3079S100CT2026-05-29
00810178889938ViveCareRHB3079M100CT2026-05-29
00810178889945ViveCareRHB3079L50CT2026-05-29
00810178889723ViveSUP3158BLKXS2026-05-27
00810178889730ViveSUP3158BLKS2026-05-27
00810178889747ViveSUP3158BLKM2026-05-27
00810178889754ViveSUP3158BLKL2026-05-27
00810178889761ViveSUP3158BLKXL2026-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810226440036ViveVIVE HEALTH LLCILH2026-06-03
00810226440043ViveVIVE HEALTH LLCILH2026-06-03
00057475274139BIOS 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
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
00609271427075BLACK FOAM WRISTDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271427082BLACK FOAM WRISTDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271427099BLACK FOAM WRISTDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271610484SPLINT, WRIST, LACE-UP, RIGHT, X-SMALLDARCO INTERNATIONAL, INC.ILH2023-02-08