Vive

Primary DI
10810113575480
Brand
Vive
Company
VIVE HEALTH LLC
Model
INS1059BLUM
Device description
Ergonomic Toe Separators (Medium)
Published
2024-01-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
OHIOrthosis, Foot Drop

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHIOrthosis, Foot DropPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810113575480PackageGS1120In Commercial Distribution
00810113575483PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081011357548010810113575480
00810113575483008101135754838101135754830810113575483

GMDN Terms#

Term, Definition table
TermDefinition
Toe separatorA foot-worn device designed to space the toes of the foot to relieve pain, pressure/friction between toes, and/or to facilitate realignment of the toes to a natural position. It is made of soft materials (e.g., silicone, polymer gel) and may be available in a variety of forms (e.g., circular channels moulded together, small disks, half moon shape); some types are in addition intended to protect and/or reduce bunion or Tailor’s bunion formation. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
047025993
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810178883943ViveSUP3111BLK2026-03-06
00810178884506ViveMOB1141BLK322026-03-06
00810178884643ViveMOB1142BLK2026-03-06
00810178884766ViveMOB1144GRY2026-03-06
00810178884773ViveMOB1144BLU2026-03-06
00810178884780ViveMOB1144PNK2026-03-06
00810178885213ViveMOB1139BLK262026-03-06
00810178885220ViveMOB1139BLK282026-03-06
00810178885237ViveMOB1139BLK302026-03-06
00810178887040ViveLVA1004DBLU2026-03-06
00810178887057ViveLVA2030DBLU2026-03-06
00810178887392Vive MobilityMOB1079GRY2026-02-18
00810178886890ViveSUP2019BGEXS2026-02-17
00810178886906ViveSUP2019BGES2026-02-17
00810178886913ViveSUP2019BGEM2026-02-17
00810178886920ViveSUP2019BGEL2026-02-17
00810178886937ViveSUP2019BGEXL2026-02-17
00810178886944ViveSUP2019BLKXS2026-02-17
00810178886951ViveSUP2019BLKS2026-02-17
00810178886968ViveSUP2019BLKM2026-02-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810178883219ViveVIVE HEALTH LLCOHI2026-02-09
00810178883226ViveVIVE HEALTH LLCOHI2026-02-09
00810178883233ViveVIVE HEALTH LLCOHI2026-02-09
10810113575473ViveVIVE HEALTH LLCOHI2024-01-12
10810113575497ViveVIVE HEALTH LLCOHI2024-01-12
00810050250771Maramed Orthopedic SystemsBIOSCULPTOR CORPORATIONOHI2023-11-29
00810050250788Maramed Orthopedic SystemsBIOSCULPTOR CORPORATIONOHI2023-11-29
00810050250795Maramed Orthopedic SystemsBIOSCULPTOR CORPORATIONOHI2023-11-29
00810050250801Maramed Orthopedic SystemsBIOSCULPTOR CORPORATIONOHI2023-11-29
00810050250818Maramed Orthopedic SystemsBIOSCULPTOR CORPORATIONOHI2023-11-29
00810050250825Maramed Orthopedic SystemsBIOSCULPTOR CORPORATIONOHI2023-11-29
00810050250832Maramed Orthopedic SystemsBIOSCULPTOR CORPORATIONOHI2023-11-29
00810050250849Maramed Orthopedic SystemsBIOSCULPTOR CORPORATIONOHI2023-11-29
G144AFO0Flint RehabFlint Rehabilitation Devices LLCOHI2023-08-10
G505MRES0Easy StepM.A.S.S. Rehab, LLCOHI2023-08-01
10810113573837VIVEVIVE HEALTH LLCOHI2023-07-24
10810113573844VIVEVIVE HEALTH LLCOHI2023-07-24
10810113573851VIVEVIVE HEALTH LLCOHI2023-07-24
10810041989052ViveSoleVIVE HEALTH LLCOHI2023-06-23
10810041989069ViveSoleVIVE HEALTH LLCOHI2023-06-23
10810041989076ViveSoleVIVE HEALTH LLCOHI2023-06-23
10810113573073ViveSoleVIVE HEALTH LLCOHI2023-06-23
10810113573080ViveSoleVIVE HEALTH LLCOHI2023-06-23
10810113573097ViveSoleVIVE HEALTH LLCOHI2023-06-23
10810113573103ViveSoleVIVE HEALTH LLCOHI2023-06-23
00733657223156AFO C-50 LG/RT WM10-11 MN9-12ALIMED, INC.OHI2022-12-01
00733657223767MULTIBOOT REGULARALIMED, INC.OHI2022-12-01
00733657287851AFO SWEDISH, WMNS RT NAT 50/CS IF BO SUGGEST BLK AFO 64332ALIMED, INC.OHI2022-12-01
00733657287868AFO SWEDISH, WMNS LF NAT 50/CS IF BO SUGGEST BLK AFO 64333ALIMED, INC.OHI2022-12-01
00733657287875AFO SWEDISH: MENS RT NAT 50/CS IF BO SUGGEST BLK AFO 64334ALIMED, INC.OHI2022-12-01