AccessGUDID - DEVICE: Copperfit (00810179881405)

GUDID

Device Identifier (DI) Information

Brand Name: Copperfit
Version or Model: CFDBLFQSWHLX
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Ideavillage Products Corp

Primary DI Number: 00810179881405
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 124259503 *Terms of Use

Device Description: Copperfit Loose Fitting Quarter Sock L/XL

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FQL	Stocking, Medical Support (For General Medical Purposes)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 759cc7b4-1b5a-491c-ac7b-390c0c87142e
Public Version Date: November 26, 2024
Public Version Number: 1
DI Record Publish Date: November 18, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES