AccessGUDID - DEVICE: Pro Comfort Universal Knee Brace (00860006377892)

GUDID

Device Identifier (DI) Information

Brand Name: Pro Comfort Universal Knee Brace
Version or Model: UKBrace
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HOME AIDE DIAGNOSTICS, INC.

Primary DI Number: 00860006377892
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 783518983 *Terms of Use

Device Description: Universal Knee Brace

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?
61652	Tubular support bandage, non-latex, reusable	A tubular, elastic non-latex fabric (e.g., polyamide, Lycra) sleeve intended to be externally worn on a limb to provide support or local pressure to a part of the body, especially a joint, for various preventative/therapeutic applications (e.g., support soft tissue injuries) while enabling movement. Sometimes referred to as a tubigrip, it may be designed to accommodate one or more anatomies (e.g., ankles, knees, wrists). It is not designed specifically to apply an even or graduated force to the limb (i.e., not a compression/pressure garment). This is a single-patient, reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IQI	Orthosis, Limb Brace

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: 9533f95f-a99b-42f3-8fa8-5799aaa799b7
Public Version Date: November 13, 2023
Public Version Number: 1
DI Record Publish Date: November 03, 2023