FDA.reportPublic FDA data

Joint Jack Company

Primary DI
00858534005042
Brand
Joint Jack Company
Company
Joint Jack Company
Model
Joint Jack Splint- extra extra large
Catalog number
1004
Published
2024-01-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
ILHSplint, Hand, And Components

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILHSplint, Hand, And ComponentsPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858534005042PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858534005042008585340050428585340050420858534005042

GMDN Terms#

Term, Definition table
TermDefinition
Hand/finger splint, single-useA prefabricated (non-customized) wearable rigid or semi-rigid device intended to immobilize an injured/diseased hand and/or finger to support, align or prevent injury during the healing process. It is applied externally to the hand/finger/wrist and typically held in place with self-retaining fasteners (e.g., Velcro bands) or bandage wraps. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
085068021
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858534005011Joint Jack CompanyJoint Jack Splint- medium10742024-01-16
00858534005028Joint Jack CompanyJoint Jack Splint- large10542024-01-16
00858534005035Joint Jack CompanyJoint Jack Splint- extra large10242024-01-16
00858534005059Joint Jack Company"Joint-Spring 7"""11542024-01-16
00858534005066Joint Jack Company"Joint-Spring 9"""12042024-01-16
00858534005073Joint Jack Company"Joint-Spring 11"""12542024-01-16
00858534005110Joint Jack CompanyJoint Cinch Strap13532024-01-16
00858534005127Joint Jack CompanyDystrophile15022024-01-16
00858534005141Joint Jack Company"Hand Wrap 2"""14552024-01-16
00858534005158Joint Jack Company"Hand Wrap 3"""14562024-01-16
00858534005165Joint Jack Company"Hand Wrap 4"""14572024-01-16
00858534005172Joint Jack Company"Hand Wrap 6"""14592024-01-16
00858534005004Joint Jack CompanyJoint Jack Splint- small11042023-07-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810226440043ViveVIVE HEALTH LLCILH2026-06-03
00057475274139BIOS LivingThermor LtdILH2023-09-18
00057475210175BIOS LivingThermor LtdILH2023-09-15
00057475210182BIOS LivingThermor LtdILH2023-09-15
10680651299854HalyardO&M HALYARD, INC.ILH2023-07-31
20680651299004HalyardO&M HALYARD, INC.ILH2023-06-07
00057475210441BIOS LivingThermor LtdILH2023-03-31
00057475210472BIOS LivingThermor LtdILH2023-03-31
00609271100053DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271100152DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271100251DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271100350DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271100459DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271101050DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271101159DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271101258DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271101357DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271101456DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271427006BLACK FOAM WRISTDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271427013BLACK FOAM WRISTDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271427020BLACK FOAM WRISTDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271427037BLACK FOAM WRISTDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271427044BLACK FOAM WRISTDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271427051BLACK FOAM WRISTDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271427068BLACK FOAM WRISTDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271427075BLACK FOAM WRISTDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271427082BLACK FOAM WRISTDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271427099BLACK FOAM WRISTDARCO INTERNATIONAL, INC.ILH2023-02-08