FDA.reportPublic FDA data

DARCO® Bungee wrist brace

Primary DI
00609271100350
Brand
DARCO® Bungee wrist brace
Company
DARCO INTERNATIONAL, INC.
Model
9BW3L
Catalog number
9BW3L; BW3-L
Device description
Large Black Left
Published
2023-02-08
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
10609271100357PackageGS14In Commercial Distribution
20609271100354PackageGS112In Commercial Distribution
00609271100350PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060927110035710609271100357
2060927110035420609271100354
00609271100350006092711003506092711003500609271100350

GMDN Terms#

Term, Definition table
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.

Regulatory Flags#

DUNS number
184231298
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00609271999336Aircore™ Offloading InsoleACI02026-07-20
00609271999343Aircore™ Offloading InsoleACI12026-07-20
00609271999374Aircore™ Offloading InsoleACI42026-07-20
00609271999381Aircore™ Offloading InsoleACI52026-07-20
00609271999473Aircore™ Offloading InsoleACI22026-07-20
00609271999480Aircore™ Offloading InsoleACI32026-07-20
00609271989603Aircore™ Offloading InsoleACIP0602026-01-07
00609271989610Aircore™ Offloading InsoleACIP0702026-01-07
00609271989627Aircore™ Offloading InsoleACIP0752026-01-07
00609271989634Aircore™ Offloading InsoleACIP0802026-01-07
00609271989658Aircore™ Offloading InsoleACIP0902026-01-07
00609271989665Aircore™ Offloading InsoleACIP0952026-01-07
00609271989672Aircore™ Offloading InsoleACIP1002026-01-07
00609271989689Aircore™ Offloading InsoleACIP1052026-01-07
00609271989696Aircore™ Offloading InsoleACIP1102026-01-07
00609271989702Aircore™ Offloading InsoleACIP1152026-01-07
00609271989719Aircore™ Offloading InsoleACIP1202026-01-07
00609271989726Aircore™ Offloading InsoleACIP1252026-01-07
00609271989733Aircore™ Offloading InsoleACIP1302026-01-07
00609271989740Aircore™ Offloading InsoleACIP1352026-01-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810226443006ViveVIVE HEALTH LLCILH2026-10-20
00194346210794EquateWAL-MART STORES, INC.ILH2026-10-14
00810226442870ViveVIVE HEALTH LLCILH2026-10-12
00810226442887ViveVIVE HEALTH LLCILH2026-10-12
00810226442894ViveVIVE HEALTH LLCILH2026-10-12
00810226442900ViveVIVE HEALTH LLCILH2026-10-12
00810179882365CopperFitIdeavillage Products CorpILH2026-10-01
00810179882372CopperFitIdeavillage Products CorpILH2026-10-01
00810179882662CopperFitIdeavillage Products CorpILH2026-10-01
00810179882679CopperFitIdeavillage Products CorpILH2026-10-01
50609576700274Puritan®Puritan Medical ProductsILH2026-07-27
06974546525140TealmedNingbo Tealmed Emergency Products Co., Ltd.ILH2026-06-25
00810226440036ViveVIVE HEALTH LLCILH2026-06-03
00810226440043ViveVIVE HEALTH LLCILH2026-06-03
00057475274139BIOS LivingThermor LtdILH2023-09-18
00057475274313BIOS 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
B7685810200Buxton BioMedicalBUXTON BIOMEDICAL, INC.ILH2023-05-26
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
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