AccessGUDID - DEVICE: ManaMed (00810113680446)

GUDID

Device Identifier (DI) Information

Brand Name: ManaMed
Version or Model: ManaEZ Boot Pediatric - Small
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EZBPEDS
Company Name: Manamed, Inc.

Primary DI Number: 00810113680446
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 084042331 *Terms of Use

Device Description: The ManaEZ Boot Pediatric is a controlled ankle motion (CAM) walking boot for children and are to be worn to help stabilize the foot and ankle after an injury or surgery. ManaEZ Boot Pediatric boots are color coded for an easy size selection. Small: Pink Medium: Yellow Large: Teal Features and Benefits: Rocker bottom to stimulate natural gait Low profile; lightweight Anatomically-shaped plastic uprights to help facilitate a secure fit for children Easy to apply and adjust with a simple strapping and liner system Fits right and left Ideal for: Treatment of stable fractures and ankle sprains, early rehabilitation of a variety of post-surgical and post-trauma indications requiring fixed control

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?
10667	Cast boot	A boot-like device designed to be attached around a leg cast to protect and support the cast, and to assist with patient mobility. This device is generally equipped with a waterproof covering, an outer sole for walking, and closures for easy application and removal. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.	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: f9b2cf08-4a7c-4013-8830-947192759c1e
Public Version Date: July 11, 2024
Public Version Number: 2
DI Record Publish Date: June 20, 2022