Drive

Basic Information

• Brand Name: Drive
• Primary DI: 00822383284033
• Version / Model: RTL10395
• Company Name: Drive Devilbiss Healthcare
• Labeler DUNS: 867673159
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-07-10
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 4a73cc91-dcbf-4c79-a1de-5be207161862

Device Description

UniversalCrutch Access Kit 1Set/RTL,8/CS

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IPR	CRUTCH	Physical Medicine	890.3150	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50822383284038	GS1		8	In Commercial Distribution
Primary	00822383284033	GS1