AccessGUDID - DEVICE: ManaMed (00810113680200)

GUDID

Device Identifier (DI) Information

Brand Name: ManaMed
Version or Model: Cabo Elbow Left
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CE001L
Company Name: Manamed, Inc.

Primary DI Number: 00810113680200
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 084042331 *Terms of Use

Device Description: This universal-fit range-of-motion elbow brace is a great alternative to casting or repetitive splinting. Designed to treat any injury in which a limited range of elbow motion is desired. Features: Adjustable straps to fit universally. Lightweight design for comfort and ease of use. ROM hinge features flexion settings from 0-120 degrees and extension settings from 0-90 degrees.

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?
12096	Elbow immobilizer	A non-rigid external device, usually made of a fabric, used to temporarily render the elbow immovable to support healing of an injury or a surgical wound. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IQQ	Joint, Shoulder, External Limb Component

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: 9e85432d-37c3-4139-8213-0330ea26081f
Public Version Date: July 25, 2024
Public Version Number: 3
DI Record Publish Date: June 20, 2022