AccessGUDID - DEVICE: Position Health® Classic Post-Op Shoe (G0648317270030320)

GUDID

Device Identifier (DI) Information

Brand Name: Position Health® Classic Post-Op Shoe
Version or Model: 831727003032
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Walgreen Health Solutions, LLC

Primary DI Number: G0648317270030320
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 116685742 *Terms of Use

Device Description: Position Health® Classic Square Toe Post-Op Offloading Shoe. Color-Black. Size-Large.

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):	Yes
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: 989b9821-2ebc-4674-ad25-f91af0e4a5b5
Public Version Date: September 04, 2024
Public Version Number: 1
DI Record Publish Date: August 27, 2024