AccessGUDID - DEVICE: Pro Comfort Universal Lumbar Support Back Brace (00850632007140)

GUDID

Device Identifier (DI) Information

Brand Name: Pro Comfort Universal Lumbar Support Back Brace
Version or Model: 62350
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7140
Company Name: HOME AIDE DIAGNOSTICS, INC.

Primary DI Number: 00850632007140
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 783518983 *Terms of Use

Device Description: • User for: Postural support, Chronic back pain, Lumbar strains or sprains, Post operative rehabilitation, Lumbar instability • The Pro Comfort Back Brace provides stabilization of the spine and restriction of the pelvis. This, in turn, relieves the pressure on the lumbar discs which helps alleviate pain and increase rehabilitation. • The ergonomic design allows it to be comfortably worn under clothing. • One Size fits all. Adjustable Size

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?
41029	Lumbosacral spine orthosis, hernia/ptosis support	A cloth orthopaedic corset designed to encompass the lumbosacral spine region of the trunk to support or immobilize deformities, fractures, sprains, or strains of the spine through abdominal compression, as well as to provide support for abdominopelvic hernias/ptosis. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
MRI	Orthosis, Truncal/Orthosis, Limb

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: Yes
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: 4086c9ff-8e83-4000-8546-eb47b903cb0e
Public Version Date: September 07, 2018
Public Version Number: 1
DI Record Publish Date: August 07, 2018