AccessGUDID - DEVICE: ManaMed (00850998008225)

GUDID

Device Identifier (DI) Information

Brand Name: ManaMed
Version or Model: Royal Boot Air Medium
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RB001M
Company Name: Manamed, Inc.

Primary DI Number: 00850998008225
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 084042331 *Terms of Use

Device Description: The Royal Boot is a tall pneumatic walker boot built with a unique rocker bottom to simulate natural gait. Athletic bottom design Large air bladder creates a larger surface for contact pressure to control swelling and ensure snug fit

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: e4388ee0-dac0-4ba3-9b17-b896691f84ed
Public Version Date: July 11, 2024
Public Version Number: 2
DI Record Publish Date: June 20, 2022