FDA.report

Vive

Primary DI
10810113570546
Brand
Vive
Company
VIVE HEALTH LLC
Model
RHB2096BLKM
Device description
Closed Toe Post Op Shoe (Medium)
Published
2023-07-10
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

Related Records

Product Codes

CodeName
IPGShoe, Cast

Product Code Classifications

CodeDeviceSpecialtyClass
IPGShoe, CastPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10810113570546PackageGS124In Commercial Distribution
00810113570549PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081011357054610810113570546
00810113570549008101135705498101135705490810113570549

GMDN Terms

TermDefinition
Orthotic shoe, non-customizedA prefabricated (non-customized) footwear designed as a shoe intended to support, align, prevent, and compensate for or correct deformities of the feet to help improve function and/or for post-operative therapy. This is a reusable device.

Sterilization Methods

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 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 DIBrandCompanyProduct codePublished
G0648317270026770GAITKEEPER® Cast Shoe Walgreen Health Solutions, LLCIPG2024-08-27
G0648317270026840GAITKEEPER® Cast Shoe Walgreen Health Solutions, LLCIPG2024-08-27
G0648317270026910GAITKEEPER® 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