AccessGUDID - DEVICE: ManaMed (00810113681764)

GUDID

Device Identifier (DI) Information

Brand Name: ManaMed
Version or Model: EZOA Right
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OFF001R
Company Name: Manamed, Inc.

Primary DI Number: 00810113681764
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 084042331 *Terms of Use

Device Description: The EZOA is a universal OA brace that allows for a varus or valgus tilt in one brace. Indicated for patients with knee arthritis. Low profile, single upright hinge for daily activities Adjustment wrench allows for easy adjustment Straps and cushions designed for all day support Lightweight, easy to use Universally sized, but left or right specific

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?
41065	Knee support orthosis	A stand-alone prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or to improve function of the knee; it may incorporate hinges for improved support. It is not a component of a larger device assembly. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ITQ	Joint, Knee, External 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: 4877d529-3258-476d-9f6a-1096c77194f8
Public Version Date: July 11, 2024
Public Version Number: 3
DI Record Publish Date: June 21, 2022