AccessGUDID - DEVICE: DARCO® PegContour™ Insole (00609271166202)

GUDID

Device Identifier (DI) Information

Brand Name: DARCO® PegContour™ Insole
Version or Model: PCI-W1-L
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PCI-W1-L
Company Name: Darco (Europe) GmbH

Primary DI Number: 00609271166202
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 343551081 *Terms of Use

Device Description: WS Blue/Grey for MedSurg/-Pro™, Relief Dual®/Plus, Relief Insert™ Walker

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:	Yes
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?
41575	Orthotic insole, prefabricated, non-antimicrobial	A prefabricated shoe insert typically available for use by a layperson intended to provide supplemental support for the arch and/or heel of the foot; it does not include an antimicrobial agent(s). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMP	Protector, skin pressure

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: 61efb9d4-d371-4bf5-96ba-112b1594c278
Public Version Date: July 08, 2025
Public Version Number: 3
DI Record Publish Date: February 08, 2023