FDA.reportPublic FDA data

CopperFit

Primary DI
00810179882365
Brand
CopperFit
Company
Ideavillage Products Corp
Model
CFDAGLSM, CFMOBGLSM
Device description
Copper Fit Dual Action Compression Gloves SM
Published
2026-10-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00810179882365PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810179882365008101798823658101798823650810179882365

GMDN Terms#

Term, Definition table
TermDefinition
Compression/pressure gloveA device in the form of a short or long glove intended to tightly fit over the hand(s) to apply compression/pressure (i.e., graduated or even-force), typically to control oedema, swelling and/or scarring due to arthritis or injuries, and/or to manage lymphoedema; it is not a strip/roll binder, shirt or tubular support bandage. It is typically made of cotton or synthetic elastic material (e.g., Lycra and Spandex) and may be available with openings for fingers and/or with integrated sleeves that may reach the wrist, elbow, or axilla; it does not include antimicrobial features. This is a reusable device.

Regulatory Flags#

DUNS number
124259503
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810179882211CopperFitCFPROAIRBKSM, CFPROAIRBKSM1002026-10-01
00810179882228CopperFitCFMAXBACKSM2026-10-01
00810179882235CopperFitCFMAXBACKLXL2026-10-01
00810179882242CopperFitCFMAXBACK2X3X2026-10-01
00810179882259CopperFitCFDABACK1SZ2026-10-01
00810179882266CopperfitCFIADARSM2026-10-01
00810179882273CopperfitCFIADARMD2026-10-01
00810179882280CopperfitCFIADARLG2026-10-01
00810179882297CopperfitCFIADARXL2026-10-01
00810179882327CopperfitCFHYDSKWHSMW2026-10-01
00810179882334CopperfitCFHYDSKWHLXW2026-10-01
00810179882341CopperfitCFDACPSKBLSM2026-10-01
00810179882358CopperfitCFDACPSKBLLX2026-10-01
00810179882372CopperFitCFDAGLLXL, CFMOBGLLXL2026-10-01
00810179882389CopperfitCFPROAIRKNSM2026-10-01
00810179882396CopperfitCFPROAIRKNLXL2026-10-01
00810179882402CopperFitCFPROAIRBKLXL, CFPROAIRLXL1002026-10-01
00810179882419CopperfitCFIPKNSM242026-10-01
00810179882426CopperfitCFIPKNLXL242026-10-01
00810179882488CopperfitCFRR360SM2026-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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