Forsure

Basic Information

• Brand Name: Forsure
• Primary DI: 00897633001685
• Version / Model: 16402001
• Catalog Number: 16402001
• Company Name: FORSURE MEDICAL PRODUCTS LLC
• Labeler DUNS: 033809722
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-02-12
• Public Version: 3
• Public Version Date: 2021-04-07
• Public Version Status: Update
• Public Device Record Key: 47658c9d-8da9-43a3-b5e8-83cb3b22309e

Device Description

A non-sterile device made of a non-conductive material intended to be used as a physical barrier on a shoe to prevent cross-contamination between the shoe and the environment. This is a single-use device.

Device Characteristics

• Single Use: Yes
• 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: Yes

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	878.4040	1

GMDN Terms

Code	Name	Definition	Implantable	Status
15056	Shoe cover	A loose fabric covering intended to be placed over a shoe to create a physical barrier to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the shoe and the environment, or a patient and staff. It is typically used in areas such as examination rooms or operating theatres and may be conductive, to reduce the risk of static electricity, or non-conductive. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20897633001689	GS1	MASTER CASE	5	In Commercial Distribution
Primary	00897633001685	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			XL, BLUE, NON SKID

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: STORE IN DRY CONDITIONS