AccessGUDID - DEVICE: ManaMed (00810113680392)

GUDID

Device Identifier (DI) Information

Brand Name: ManaMed
Version or Model: ManaEZ Ankle 02 XX-Large
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EZANKLE02XXL
Company Name: Manamed, Inc.

Primary DI Number: 00810113680392
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 084042331 *Terms of Use

Device Description: This a low profile, quick-fitting figure 8 ankle brace to provide optimal ankle stabilization. Figure 8 stabilizing straps replicate athletic ankle taping Low profile brace fits into all types of footwear Universally sized for left or right ankle Designed by athletes for athletes

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?
36206	Ankle/foot orthosis	A prefabricated (non-customized) externally applied and wearable appliance or apparatus intended to encompass the ankle joint, or the ankle and foot, to support, align, prevent, or correct orthopaedic deformities/injuries or to improve function of the ankle and/or foot through actions such as alignment, hinge-support, or dorsiflexion assistance. It may also be intended to offload and redistribute foot pressures that affect pedal circulation to improve blood flow and help heal diabetic foot ulcers or postsurgical wounds, and may include patient adaptable plantar inserts. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ITW	Joint, Ankle, 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: 0e10fb58-db22-4150-8e99-c9a8ab6dee0a
Public Version Date: July 11, 2024
Public Version Number: 2
DI Record Publish Date: June 20, 2022