AccessGUDID - DEVICE: Unite Medical® (00850052096922)

GUDID

Device Identifier (DI) Information

Brand Name: Unite Medical®
Version or Model: Tall Walking Boot - Pneumatic (Small)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PWB6061-S-T
Company Name: Unite Medical, LLC

Primary DI Number: 00850052096922
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117553945 *Terms of Use

Device Description: Introducing the Unite Medical® Tall Pneumatic Walking Boot, designed for superior support and comfort in treating soft tissue injuries, grade 2 and 3 sprains, stable fractures, and post-operative stabilization. This boot features an inflatable bladder for enhanced immobilization, a lightweight low rocker profile for greater comfort, and a cushioned heel for optimal energy absorption. Its versatile design fits either foot and promotes a natural gait pattern for improved mobility.

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":	Yes
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: aa310e63-ad73-4d0f-931a-addec665eced
Public Version Date: June 28, 2024
Public Version Number: 1
DI Record Publish Date: June 20, 2024