AccessGUDID - DEVICE: DARCO® PegAssist™ Insole (00609271333154)

GUDID

Device Identifier (DI) Information

Brand Name: DARCO® PegAssist™ Insole
Version or Model: PAS-W1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PAS-W1
Company Name: DARCO INTERNATIONAL, INC.

Primary DI Number: 00609271333154
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 184231298 *Terms of Use

Device Description: WS Blue 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?
60597	Pressure-management insole, prefabricated	A prefabricated (non-customized) device intended to be worn against the feet to reduce peak foot pressures and improve pedal circulation in a patient who has, or who is at risk of developing, peripheral vascular disease (PVD) or diabetic foot disease. It typically contains a gel-filled cushion intended to distribute force to facilitate improved blood flow within the foot. 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: b3d650e8-0553-494d-9b20-ebd2346838e3
Public Version Date: February 16, 2023
Public Version Number: 1
DI Record Publish Date: February 08, 2023