AccessGUDID - DEVICE: DRIVEMEDICAL (00050428531709)

GUDID

Device Identifier (DI) Information

Brand Name: DRIVEMEDICAL
Version or Model: 792502
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Drive Devilbiss Healthcare

Primary DI Number: 00050428531709
Issuing Agency: GS1
Commercial Distribution End Date: August 06, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 867673159 *Terms of Use

Device Description: Walkers, All TypesAccessories Product Description: UtilityReplaceTips,1",Gry,8pr/cs, CVS

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?
15702	Walking aid tip	A device designed as a formed piece of non-slip material (e.g., rubber or suitable plastic) that is attached to the ground-contacting end of a walking aid (e.g., a walking stick, crutch, or walking frame) to promote a secure purchase to the contact surface (ground or floor surfaces) thereby increasing the safety factor. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ITJ	WALKER, MECHANICAL

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: f128115c-4bc1-4c01-bb63-34924eee9876
Public Version Date: August 12, 2024
Public Version Number: 2
DI Record Publish Date: June 21, 2019