P&P Medical Surgical LLC

Basic Information

• Brand Name: P&P Medical Surgical LLC
• Primary DI: G026035001
• Version / Model: 03500
• Company Name: P&P Medical Surgical LLC
• Labeler DUNS: 022925151
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-12-13
• Public Version: 1
• Public Version Date: 2021-12-22
• Public Version Status: New
• Public Device Record Key: eea915f5-acf0-4f93-938c-5f3a7ffd80a1

Device Description

Disposable Shoe & Working Boot Covers Waterproof Durable Non-Slip Resistant Polypropylene for Healthcare & Medical Offices Indoor Carpet Floor Protection Universal Size Box of 100 (50 Pairs)

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: MR Safe
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• 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
Primary	G026035001	HIBCC