AccessGUDID - DEVICE: REAR ANTI-TIPPER W/WHEELS 10/CA (00733657286670)

GUDID

Device Identifier (DI) Information

Brand Name: REAR ANTI-TIPPER W/WHEELS 10/CA
Version or Model: 843110
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2970011190
Company Name: ALIMED, INC.

Primary DI Number: 00733657286670
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 056007248 *Terms of Use

Device Description: No description.

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?
32987	Wheelchair antitip device	A device that is added to the front or rear of a wheelchair to prevent upset by limiting the degree of forward or backward tilting that can occur. The device, typically made of metal, may appear as a rod-like arm with or without a wheel at its distal end, and is mounted to the wheelchair in pairs. The device should have sufficient strength to function as intended when the wheelchair is carrying its maximum load on the steepest intended slope.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IMR	DEVICE, ANTI-TIP, 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: 66c7c0e0-339f-4bf5-9f3f-444b594d1157
Public Version Date: February 26, 2024
Public Version Number: 3
DI Record Publish Date: December 01, 2022