AccessGUDID - DEVICE: DARCO® GentleStep™ Shoe (00609271231085)

GUDID

Device Identifier (DI) Information

Brand Name: DARCO® GentleStep™ Shoe
Version or Model: GS105XB
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GS105XB
Company Name: DARCO INTERNATIONAL, INC.

Primary DI Number: 00609271231085
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 184231298 *Terms of Use

Device Description: Women's 10.5 / Men's 9 Black Extra-wide width

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?
31041	Orthotic shoe, non-customized	A prefabricated (non-customized) footwear designed as a shoe intended to support, align, prevent, and compensate for or correct deformities of the feet to help improve function and/or for post-operative therapy. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNP	ORTHOSIS, CORRECTIVE SHOE

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: 9734607e-c822-44fa-8e6f-9f6d237ece3a
Public Version Date: February 21, 2023
Public Version Number: 1
DI Record Publish Date: February 13, 2023