All Gel Antibacterial Bunion Shield, Hallux, Large, 1pc/bag

Basic Information

• Brand Name: All Gel Antibacterial Bunion Shield, Hallux, Large, 1pc/bag
• Primary DI: 00614464065156
• Version / Model: 6515
• Company Name: Silipos Holding LLC
• Labeler DUNS: 056112948
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-05
• Public Version: 1
• Public Version Date: 2022-08-15
• Public Version Status: New
• Public Device Record Key: 5c1a7d2f-71c8-426d-9b01-97704337d555

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: Yes
• Has Manufacturing Date: Yes
• 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
FMP	Protector, Skin Pressure	General Hospital	880.6450	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13565	Bunion shield	A pad used to protect a bunion that has formed on the base of the big toe. It is typically ring-shaped, made of a thick material and worn over the bunion. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00614464065156	GS1