AccessGUDID - DEVICE: Rhino (00810060887868)

GUDID

Device Identifier (DI) Information

Brand Name: Rhino
Version or Model: Wrist/Forearm Support - 10" Adolescent Right
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 27344
Company Name: MD ORTHOPAEDICS, INC.

Primary DI Number: 00810060887868
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 146220269 *Terms of Use

Device Description: Wrist/Forearm Support - 10" Adolescent Right

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?
12102	Wrist immobilizer, reusable	A rigid external support designed to temporarily render the wrist immovable as therapy for non-displaced fractures, strains, sprains, and muscle injuries of the wrist. The rigid support typically includes a wrap which may be held in place with a fastener such as Velcro; it is available in a variety of sizes. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IOY	Support, Arm

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: 4f468265-195f-4f34-baf5-49da96110be2
Public Version Date: July 25, 2024
Public Version Number: 2
DI Record Publish Date: December 21, 2023