AccessGUDID - DEVICE: Relief (00850056031004)

GUDID

Device Identifier (DI) Information

Brand Name: Relief
Version or Model: Insole with Pcell cover, pair
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Solo Laboratories, Inc.

Primary DI Number: 00850056031004
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 161003025 *Terms of Use

Device Description: Ideal for the sensitive diabetic foot, the SOLO Relief® and SOLO Relief+® are A5514 Medicare approved inserts. The Relief and Relief+ Custom Orthotic are indicated for Type I Diabetics and Type II Diabetics with pre-ulcerative calluses, poor circulation, diabetics ulcers, previous amputations or partial amputation of either foot.

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):	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?
62870	Orthotic insole, custom-made	A shoe insert intended to provide supplemental support for the sole, arch, and/or heel of the foot and specifically produced to meet an individual's special requirements, having been prescribed by a relevant healthcare professional. It is made of various materials (e.g., cork, rubber, foam, textile) and may be of modular design by assembly of various pre-made components. This is a reusable device intended for single-patient use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KYS	Insoles, Medical

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: 5079d148-7731-4e66-8c06-b505da5ba21a
Public Version Date: September 07, 2023
Public Version Number: 1
DI Record Publish Date: August 30, 2023