FDA UDI
In Commercial Distribution
🇺🇸 United States
Copperfit
DI: 00810179881405
·
Model: CFDBLFQSWHLX
·
Ideavillage Products Corp
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Copperfit
- Primary DI
- 00810179881405
- Version / Model
- CFDBLFQSWHLX
- Company Name
- Ideavillage Products Corp
- Labeler DUNS
- 124259503
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-18
- Public Version
- 1
- Public Version Date
- 2024-11-26
- Public Version Status
- New
- Public Device Record Key
- 759cc7b4-1b5a-491c-ac7b-390c0c87142e
Device Description
Copperfit Loose Fitting Quarter Sock L/XL
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FQL | Stocking, Medical Support (For General Medical Purposes) | General Hospital | 880.5780 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58132 | Therapeutic diabetic sock | A tubular device typically worn on the feet of a diabetic patient intended to help maintain foot health and promote wound healing through specific design features (e.g., non-binding cuff, no/flat seams, moisture control materials, and/or non-wrinkling materials) combined with a special therapeutic feature (e.g., inclusion of fibres intended to absorb patient electromagnetic energy and return energy to the patient to help increase vascular flow and oxygen levels in the blood). The device is intended for daily use in the home and healthcare facility. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810179881405 | GS1 |