AccessGUDID - DEVICE: BEST BACK (05391512281502)

GUDID

Device Identifier (DI) Information

Brand Name: BEST BACK
Version or Model: 007 size L IRON
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 007
Company Name: INDACO SRL

Primary DI Number: 05391512281502
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 338470646 *Terms of Use

Device Description: Best-Back offers a selection of back supports in a variety of colors and sizes. Do you want to match the chrome on your bike – select the “Iron”. Are you inspired by the orange of your favorite motorcycle brand – select “Orange”. Do you prefer the softer side of pink – select “Lady”. We have a size and a style for everyone! For the realization of this garment, synthetic fibers have been mainly used which make it extremely robust and durable over time. Inside, a particular mesh fabric has been chosen consisting of many small cells that make the band breathable and light. On the outside, on the other hand, high quality Velcro has been used which allows the strap fastening system to hook firmly to the surface. The patented rear laces are made of leatherette with a three-dimensional finish with a carbon fiber effect. Indications Muscle tension or contracture Muscle tear Muscle spasm Muscle weakness Disc hernia

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?
33031	Lumbar spine orthosis	A prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to encompass the lumbar spine region of the trunk to support or immobilize deformities, fractures, sprains, or strains of the spine. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IQE	Orthosis, Lumbar

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: a723cc4a-5621-4142-96b1-b9f97eddb46c
Public Version Date: March 01, 2024
Public Version Number: 1
DI Record Publish Date: February 22, 2024