Protect U Guard Silicone Foam Sterile Dressing

Basic Information

• Brand Name: Protect U Guard Silicone Foam Sterile Dressing
• Primary DI: B086191311
• Version / Model: P19131
• Company Name: PROTECT U GUARD, LLC
• Labeler DUNS: 080070945
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2020-08-21
• Public Version: 2
• Public Version Date: 2021-06-22
• Public Version Status: Update
• Public Device Record Key: 4cbd4f60-2a3b-4fc2-80ee-274a43fa5bea

Device Description

Protect U Guard Silicone Foam Sterile Dressing 10x10cm

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: No
• 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
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	878.4020	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44970	Exudate-absorbent dressing, non-gel, non-antimicrobial	A wound covering intended to assist in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) and often by creating a moist wound-healing environment. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudates, but may be designed to absorb and remove exudates (e.g., by capillary action); it does not contain an antimicrobial agent, but may include antioxidant properties. The device is available in a variety of forms (e.g., flat sheet/film-like, impregnated pouches, filled sachets, lyophilized matrix, ribbon, rope, foam, liquid, or powder). After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B086291312	HIBCC	CARTON	540	In Commercial Distribution
Primary	B086191311	HIBCC
Unit of Use	B086091310	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Width	10	Centimeter
Length	10	Centimeter