FDA.reportPublic FDA data

Copperfit

Primary DI
00810179882457
Brand
Copperfit
Company
Ideavillage Products Corp
Model
CFDAELGELLXL
Device description
CF DUAL ACTION ELBOW GEL-LG -XL
Published
2026-06-01
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
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
00810179882457PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810179882457008101798824578101798824570810179882457

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.

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
00810179881498CopperfitCFDAELGELSM2026-06-01
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
00810179881238CopperfitCFRRWWOS2024-11-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810179881498CopperfitIdeavillage 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
00810179880378CopperfitIdeavillage 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