AccessGUDID - DEVICE: Unite Medical® (00850012035329)

GUDID

Device Identifier (DI) Information

Brand Name: Unite Medical®
Version or Model: Suspension Sleeve (Universal)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SS2397
Company Name: Unite Medical, LLC

Primary DI Number: 00850012035329
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® suspension sleeve is worn in conjunction with a knee orthosis to help suspend brace and prevent knee orthosis from migrating.

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?
44214	Orthosis suspension unit	A component of an orthosis that holds the orthosis to the body at various anatomical sites, e.g., the pelvis or malleolus. 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: 2f983067-49d3-4bed-9cbd-9075c1d99b89
Public Version Date: January 05, 2024
Public Version Number: 1
DI Record Publish Date: December 28, 2023