Vive

Primary DI
10818323026488
Brand
Vive
Company
VIVE HEALTH LLC
Model
SUP1037BLKL
Device description
Soft Night Splint (Black) (Large)
Published
2022-09-02
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
IPGShoe, Cast

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IPGShoe, CastPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818323026488PackageGS120In Commercial Distribution
00818323026481PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081832302648810818323026488
00818323026481008183230264818183230264810818323026481

GMDN Terms#

Term, Definition table
TermDefinition
Ankle/foot orthosisA prefabricated (non-customized) externally applied and wearable appliance or apparatus intended to encompass the ankle joint, or the ankle and foot, to support, align, prevent, or correct orthopaedic deformities/injuries or to improve function of the ankle and/or foot through actions such as alignment, hinge-support, or dorsiflexion assistance. It may also be intended to offload and redistribute foot pressures that affect pedal circulation to improve blood flow and help heal diabetic foot ulcers or postsurgical wounds, and may include patient adaptable plantar inserts. 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
G0648317270026770GAITKEEPERĀ® Cast Shoe Walgreen Health Solutions, LLCIPG2024-08-27
G0648317270026840GAITKEEPERĀ® Cast Shoe Walgreen Health Solutions, LLCIPG2024-08-27
G0648317270026910GAITKEEPERĀ® Cast Shoe Walgreen Health Solutions, LLCIPG2024-08-27
10810113576395CoreTechVIVE HEALTH LLCIPG2024-06-10
10810113576401CoreTechVIVE HEALTH LLCIPG2024-06-10
10810113576418CoreTechVIVE HEALTH LLCIPG2024-06-10
10810113576425CoreTechVIVE HEALTH LLCIPG2024-06-10
10810113575978VIVEVIVE HEALTH LLCIPG2024-06-05
00810060883488Rhino MD ORTHOPAEDICS, INC.IPG2023-12-20
00810060883587Rhino MD ORTHOPAEDICS, INC.IPG2023-12-20
00810060883594Rhino MD ORTHOPAEDICS, INC.IPG2023-12-20
00810060888025Rhino MD ORTHOPAEDICS, INC.IPG2023-12-20
00810060888032Rhino MD ORTHOPAEDICS, INC.IPG2023-12-20
00810060888049Rhino MD ORTHOPAEDICS, INC.IPG2023-12-20
10810041980059ViveVIVE HEALTH LLCIPG2023-10-18
20810041980056ViveVIVE HEALTH LLCIPG2023-10-18
10810041980066ViveVIVE HEALTH LLCIPG2023-10-18
10810041980073ViveVIVE HEALTH LLCIPG2023-10-18
10810041980080ViveVIVE HEALTH LLCIPG2023-10-18
10810041980097ViveVIVE HEALTH LLCIPG2023-10-18
10810041980103ViveVIVE HEALTH LLCIPG2023-10-18
10810041980110ViveVIVE HEALTH LLCIPG2023-10-18
10810041980127ViveVIVE HEALTH LLCIPG2023-10-18
10810041980134ViveVIVE HEALTH LLCIPG2023-10-18
10818323029649ViveVIVE HEALTH LLCIPG2023-10-18
10818323029656ViveVIVE HEALTH LLCIPG2023-10-18
10818323029663ViveVIVE HEALTH LLCIPG2023-10-18
10818323029670ViveVIVE HEALTH LLCIPG2023-10-18
10818323029687ViveVIVE HEALTH LLCIPG2023-10-18
00816591011116Elite OrthopaedicsElite Orthopaedics, Inc.IPG2023-08-15