DONJOY

Basic Information

• Brand Name: DONJOY
• Primary DI: 00888912015356
• Version / Model: 11-0822-9-00000
• Company Name: DJO, LLC
• Labeler DUNS: 081840873
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-23
• Public Version: 1
• Public Version Date: 2023-01-31
• Public Version Status: New
• Public Device Record Key: e3426979-5a99-439c-9054-a4623396f11d

Device Description

DRESSING,UNIVERSAL,STERILE

Device Characteristics

• Single Use: Yes
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NAD	Dressing, wound, occlusive	General, Plastic Surgery	878.4020	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31050	Assistive sock/pantyhose dressing device	A device designed to assist a person with a disability to put on and take off their socks, stockings, and tights (pantyhose).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00888912015356	GS1