AccessGUDID - DEVICE: Monty 3D QuickShift Sturdy (B8961133110)

GUDID

Device Identifier (DI) Information

Brand Name: Monty 3D QuickShift Sturdy
Version or Model: 11.3311
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: REHAdapt Engineering GmbH & Co. KG

Primary DI Number: B8961133110
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 340146982 *Terms of Use

Device Description: M3D wheelchair mount with a RotLok base for extra stability (e.g. mounting on the left side). Tube lengths: 200 x 500 x 400 mm (8 x 20 x 16"). Max. load capacity: 3.0 kg (6.6 lbs). Frame clamp not included.

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):	No
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?
61434	Portable active medical device mount	A device intended to be fixed (e.g., to a healthcare facility wall, ambulance, trolley, floor) to enable easy and secure short-term and/or long-term mounting of a portable active medical device (e.g., an electronic/electromechanical device such as a barcode reader, emergency suction system, humidifier, resuscitator) during use; the parent device is not included. It may be dedicated to mounting a specific parent device, or non-dedicated. It may in addition allow for integration of a power cable, which may be included; it may provide for storage of the device but is not a dedicated storage mount.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNO	Accessories, Wheelchair

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: ca297798-99f8-41bd-ad52-bf4f6ffd8f6e
Public Version Date: July 25, 2024
Public Version Number: 2
DI Record Publish Date: July 26, 2022