AccessGUDID - DEVICE: ManaMed (00810113681993)

GUDID

Device Identifier (DI) Information

Brand Name: ManaMed
Version or Model: Cabo Knee XX-Large Left
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TRBL45XXL2
Company Name: Manamed, Inc.

Primary DI Number: 00810113681993
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 084042331 *Terms of Use

Device Description: The Cabo (formerly Trailblazer) is one of the lightest double upright braces on the market. This innovative system features an aluminum alloy frame with a proprietary quick fitting magnetic buckle system. Lightweight and low-profile Magnetic quick releasing buckles Pivoting condyle pads for an optimal fit Step through design

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: e8e9dea0-abcd-4cf3-a62b-386a50bda733
Public Version Date: July 11, 2024
Public Version Number: 3
DI Record Publish Date: June 21, 2022