Wenzellite

Basic Information

• Brand Name: Wenzellite
• Primary DI: 00822383901183
• Version / Model: FC100-2GB
• Company Name: Drive Devilbiss Healthcare
• Labeler DUNS: 867673159
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2020-02-01
• Public Version: 1
• Public Version Date: 2020-02-10
• Public Version Status: New
• Public Device Record Key: 0469c41e-62c6-4f07-b4bc-85abb8fab4e9

Device Description

Wenzelite Pediatric Crutches Product Description Forearm Crutch, Small, Blue, Pair

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• 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
31115	Axillary crutch	A staff-like mobility aid used to assist a person with a disability to support their weight while walking. The device has one leg, a padded hand support at the level of the user's wrist, and an under-arm (the armpit or axilla) padded platform. The pads are typically made of non-slip material (e.g., rubber, glycerin gel, sheepskin). The device may be adjustable in length and is typically made of wood or metal [e.g., aluminium (Al), titanium (Ti)].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00822383901183	GS1
Unit of Use	50822383901188	GS1