FDA.reportPublic FDA data

Vive

Primary DI
00810041980090
Brand
Vive
Company
VIVE HEALTH LLC
Model
SUP2024LGRYXS
Device description
Wrist Immobilizer (Left) Grey XS
Published
2023-10-18
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
IPGShoe, Cast

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IPGShoe, CastPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810041980097PackageGS150In Commercial Distribution
00810041980090PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081004198009710810041980097
00810041980090008100419800908100419800900810041980090

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
00810178889723ViveSUP3158BLKXS2026-05-27
00810178889730ViveSUP3158BLKS2026-05-27
00810178889747ViveSUP3158BLKM2026-05-27
00810178889754ViveSUP3158BLKL2026-05-27
00810178889761ViveSUP3158BLKXL2026-05-27
00810178889778ViveSUP3159BLKXS2026-05-27
00810178889785ViveSUP3159BLKS2026-05-27
00810178889792ViveSUP3159BLKM2026-05-27
00810178889808ViveSUP3159BLKL2026-05-27
00810178889815ViveSUP3159BLKXL2026-05-27
00810178889822ViveSUP3160BLKXS2026-05-27
00810178889839ViveSUP3160BLKS2026-05-27
00810178889846ViveSUP3160BLKM2026-05-27
00810178889853ViveSUP3160BLKL2026-05-27
00810178889860ViveSUP3160BLKXL2026-05-27
00810178889877ViveSUP3161BLKXS2026-05-27
00810178889884ViveSUP3161BLKS2026-05-27
00810178889891ViveSUP3161BLKM2026-05-27
00810178889907ViveSUP3161BLKL2026-05-27
00810178889914ViveSUP3161BLKXL2026-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00749756888349DeRoyalDEROYAL INDUSTRIES, INC.IPG2026-04-02
00749756888356DeRoyalDEROYAL INDUSTRIES, INC.IPG2026-04-02
00749756888370DeRoyalDEROYAL INDUSTRIES, INC.IPG2026-04-02
00749756888387DeRoyalDEROYAL INDUSTRIES, INC.IPG2026-04-02
00749756888394DeRoyalDEROYAL INDUSTRIES, INC.IPG2026-04-02
00749756888400DeRoyalDEROYAL INDUSTRIES, INC.IPG2026-04-02
00810178880577Vive VIVE HEALTH LLCIPG2025-10-14
00810178880584Vive VIVE HEALTH LLCIPG2025-10-14
00810178880591Vive VIVE HEALTH LLCIPG2025-10-14
00810178880607Vive VIVE HEALTH LLCIPG2025-10-14
00810178880614Vive VIVE HEALTH LLCIPG2025-10-14
00810178880621Vive VIVE HEALTH LLCIPG2025-10-14
00810178880638Vive VIVE HEALTH LLCIPG2025-10-14
G0648317270026770GAITKEEPER® Cast Shoe POSITION HEALTH, LLCIPG2024-08-27
G0648317270026840GAITKEEPER® Cast Shoe POSITION HEALTH, LLCIPG2024-08-27
G0648317270026910GAITKEEPER® Cast Shoe POSITION HEALTH, LLCIPG2024-08-27
G0648317270027520Position Health® Classic Post-Op Shoe POSITION HEALTH, LLCIPG2024-08-27
G0648317270027690Position Health® Classic Post-Op ShoePOSITION HEALTH, LLCIPG2024-08-27
G0648317270027760Position Health® Classic Post-Op ShoePOSITION HEALTH, LLCIPG2024-08-27
G0648317270027830Position Health® Classic Post-Op ShoePOSITION HEALTH, LLCIPG2024-08-27
G0648317270027900Position Health® Classic Post-Op ShoePOSITION HEALTH, LLCIPG2024-08-27
00810113576398CoreTechVIVE HEALTH LLCIPG2024-06-10
00810113576404CoreTechVIVE HEALTH LLCIPG2024-06-10
00810113576411CoreTechVIVE HEALTH LLCIPG2024-06-10
00810113576428CoreTechVIVE HEALTH LLCIPG2024-06-10
10810113576395CoreTechVIVE HEALTH LLCIPG2024-06-10
10810113576401CoreTechVIVE HEALTH LLCIPG2024-06-10
10810113576418CoreTechVIVE HEALTH LLCIPG2024-06-10
10810113576425CoreTechVIVE HEALTH LLCIPG2024-06-10
00810113575971VIVEVIVE HEALTH LLCIPG2024-06-05