Quickloop Abscess Treatment Device

Basic Information

• Brand Name: Quickloop Abscess Treatment Device
• Primary DI: B762M01000010
• Version / Model: M01-0-0005
• Catalog Number: M01-0-0005
• Company Name: Em Device Lab, Inc
• Labeler DUNS: 080664372
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-03
• Public Version: 1
• Public Version Date: 2021-05-11
• Public Version Status: New
• Public Device Record Key: 97575564-457e-4d18-8c1b-93ed9eab1b9a

Device Description

Device for draining and irrigating cutaneous and oral fluid collections such as abscesses, seromas and hematomas.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• 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
GBX	Catheter, Irrigation	General, Plastic Surgery	878.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62389	Wound irrigation cannula	A rigid or semi-rigid tube intended to be connected to a parent device (e.g., syringe) to channel irrigation fluids (e.g., saline solution) to a skin or surgical wound for washing and removing debris; it is not intended for aspiration of fluids. This is a single-use device intended to be used in a sterile condition.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B762M01000010	HIBCC

Customer Contacts

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