AccessGUDID - DEVICE: Unite Medical® (00850012035497)

GUDID

Device Identifier (DI) Information

Brand Name: Unite Medical®
Version or Model: Ankle Foot Orthosis (Right,Medium)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AFO0671R-M
Company Name: Unite Medical, LLC

Primary DI Number: 00850012035497
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117553945 *Terms of Use

Device Description: The Unite Medical® ankle foot orthosis is indicated for ankle instabilities, acute & chronic ankle sprains, hind foot arthritis, ankle tendonitis, and ankle arthritis. The ankle foot orthosis is a lightweight, low profile brace, great for extended wear.

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: c167c717-4f88-4feb-8bf5-79ad30adf3c1
Public Version Date: January 05, 2024
Public Version Number: 1
DI Record Publish Date: December 28, 2023