FDA.reportPublic FDA data

Quickloop Abscess Treatment Device

Primary DI
B762M01000010
Brand
Quickloop Abscess Treatment Device
Company
Em Device Lab, Inc
Model
M01-0-0005
Catalog number
M01-0-0005
Device description
Device for draining and irrigating cutaneous and oral fluid collections such as abscesses, seromas and hematomas.
Published
2021-05-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GBXCatheter, Irrigation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBXCatheter, IrrigationGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B762M01000010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Wound irrigation cannulaA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7372439701info@emdevicelab.com

Regulatory Flags#

DUNS number
080664372
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450022146One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450022160One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450022184One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450022306One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450022313One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450022535One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450022559One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450022566One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450022573One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450022597One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450022603One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450022665One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450022689One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450022764One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450024010One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450024027One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00840456202692JMUJMU DENTAL, INCGBX2026-07-27
00840456202708JMUJMU DENTAL, INCGBX2026-07-27
00884450014523ReSolve®, StayFIX®,Merit Medical Systems, Inc.GBX2026-07-16
00840456216750JMUJMU DENTAL, INCGBX2026-06-22
00840456216767JMUJMU DENTAL, INCGBX2026-06-22
00840456216774JMUJMU DENTAL, INCGBX2026-06-22
17350128050006LinkUS DrainInterlinked ABGBX2026-05-31
10080196995998MEDLINEMEDLINE INDUSTRIES, INC.GBX2024-12-12
10080196128839MedlineMEDLINE INDUSTRIES, INC.GBX2023-12-27
10080196997633MedlineMEDLINE INDUSTRIES, INC.GBX2023-12-27
08034139292823Thoracic Catheter, Straight Fr 18REDAX SPAGBX2021-05-07
08034139292830Thoracic Catheter, Straight Fr 21REDAX SPAGBX2021-05-07
08034139292847Thoracic Catheter, Straight Fr 24REDAX SPAGBX2021-05-07
08034139292861Thoracic Catheter, Straight Fr 30REDAX SPAGBX2021-05-07