FDA.report

Vive

Primary DI
10810041982206
Brand
Vive
Company
VIVE HEALTH LLC
Model
SUP2053BLKSM
Device description
Boxer Splint 8"
Published
2022-07-26
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
ILHSplint, Hand, And Components

Product Code Classifications

CodeDeviceSpecialtyClass
ILHSplint, Hand, And ComponentsPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10810041982206PackageGS140In Commercial Distribution
00810041982209PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081004198220610810041982206
00810041982209008100419822098100419822090810041982209

GMDN Terms

TermDefinition
Wrist/hand orthosisAn externally applied orthopaedic appliance or apparatus designed to support, correct, or improve function of the wrist and hand through actions such as alignment, hinge-support, or dorsiflexion assistance. 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
00810220800041Adler Instrument CompanyAdler, Inc.ILH2026-03-17
00817355025806KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-12
00817355025820KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-12
00817355025868KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-12
00817355026247KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-12
00810178883943ViveVIVE HEALTH LLCILH2026-03-06
00817355021976KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355025790KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355025813KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355025837KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355025844KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355025899KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355025912KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355025967KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355025974KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355025981KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355026018KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355026025KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355026032KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355026056KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355026230KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355026292KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355026360KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355026698KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355026711KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355026735KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355026896KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355026902KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355022805KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-05
00817355026667KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-05