FDA.reportPublic FDA data

Copperfit

Primary DI
00810179880378
Brand
Copperfit
Company
Ideavillage Products Corp
Model
CF2ELLG
Device description
CopperFit Freedom Elbow Sleeve L
Published
2024-11-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IRDJoint, Elbow, External Limb Component, Mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRDJoint, Elbow, External Limb Component, MechanicalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810179880378PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810179880378008101798803788101798803780810179880378

GMDN Terms#

Term, Definition table
TermDefinition
Compression/pressure tubular garmentA device in the form of a tube intended to tightly fit over and apply compression/pressure (i.e., graduated or even-force) to a part of a limb, typically for the treatment/prevention of a disorder(s) of circulation [e.g., venous insufficiency, deep vein thrombosis (DVT)], to control scarring, and/or to manage lymphoedema; it is neither a strip/roll binder, glove, sock/stocking, nor tubular support bandage. It is typically made of cotton or synthetic elastic material (e.g., Lycra and Spandex); it does not include antimicrobial features. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
124259503
Device count
1
Premarket exempt
true
Serial number
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810179881498CopperfitCFDAELGELSM2026-06-01
00810179882457CopperfitCFDAELGELLXL2026-06-01
00810179882464CopperfitCFEHAMSM2026-06-01
00810179882471CopperfitCFEHAMLXL2026-06-01
00810179881191CopperfitCFCWROS2024-11-18
00810179881245CopperfitCFRVWBR1SZ242024-11-18
00810179881252CopperfitCFAIRWROS2024-11-18
00810179881269CopperfitCFAIRAKOS2024-11-18
00810179881368CopperfitCFAIRWRSLP242024-11-18
00810179881573CopperfitCFAIRWRTHOS42024-11-18
00810179882440CopperFitCFIKNXXXL2026-01-13
00810179881924CopperfitCFRRHIP242025-03-05
00810179880439CopperfitCFRREL2025-01-28
00810179880040 CopperfitCFRRAKL1S32024-11-18
00810179880194 CopperfitCFRRBK1SZ2024-11-18
00810179880200CopperfitCFRRBKSM2024-11-18
00810179880217 CopperfitCFRRBKLXL2024-11-18
00810179880552CopperfitCFRRPASL2024-11-18
00810179880903CopperfitCFRRKNW2024-11-18
00810179880972CopperfitCFRRSHD2024-11-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810179881498CopperfitIdeavillage Products CorpIRD2026-06-01
00810179882457CopperfitIdeavillage Products CorpIRD2026-06-01
00810179880729CopperfitIdeavillage Products CorpIRD2025-02-04
00810179880309CopperfitIdeavillage Products CorpIRD2024-11-18
00810179880316CopperfitIdeavillage Products CorpIRD2024-11-18
00810179880323CopperfitIdeavillage Products CorpIRD2024-11-18
00810179880330CopperfitIdeavillage Products CorpIRD2024-11-18
00810179880347CopperfitIdeavillage Products CorpIRD2024-11-18
00810179880354 CopperfitIdeavillage Products CorpIRD2024-11-18
00810179880361CopperfitIdeavillage Products CorpIRD2024-11-18
00810179880385CopperfitIdeavillage Products CorpIRD2024-11-18
00810179880392CopperfitIdeavillage Products CorpIRD2024-11-18
00810179880408 CopperfitIdeavillage Products CorpIRD2024-11-18
00810179880415CopperfitIdeavillage Products CorpIRD2024-11-18
00810179880422CopperfitIdeavillage Products CorpIRD2024-11-18
00810179880446CopperfitIdeavillage Products CorpIRD2024-11-18
00810179880453CopperfitIdeavillage Products CorpIRD2024-11-18
05055348200792Control and Suspension SystemsHUGH STEEPER LIMITEDIRD2023-08-02
05055348201218ElbowHUGH STEEPER LIMITEDIRD2023-08-02
05055348227997Control and Suspension SystemsHUGH STEEPER LIMITEDIRD2023-08-02
05055348247742Control and Suspension SystemsHUGH STEEPER LIMITEDIRD2023-08-02
05055348247780ElbowHUGH STEEPER LIMITEDIRD2023-08-02
05055348247797ElbowHUGH STEEPER LIMITEDIRD2023-08-02
05055348248572Control and Suspension SystemsHUGH STEEPER LIMITEDIRD2023-08-02
05055348252920Control and Suspension SystemsHUGH STEEPER LIMITEDIRD2023-08-02
05055348262127ElbowHUGH STEEPER LIMITEDIRD2023-08-02
05055348262134ElbowHUGH STEEPER LIMITEDIRD2023-08-02
05055348262257Control and Suspension SystemsHUGH STEEPER LIMITEDIRD2023-08-02
05055348262288Control and Suspension SystemsHUGH STEEPER LIMITEDIRD2023-08-02
05055348201058ElbowHUGH STEEPER LIMITEDIRD2023-08-01