MesireTM Latch - Catheter Holding System

Basic Information

• Brand Name: MesireTM Latch - Catheter Holding System
• Primary DI: 18904224905709
• Version / Model: MSL
• Catalog Number: MSL
• Company Name: MERIL LIFE SCIENCES PRIVATE LIMITED
• Labeler DUNS: 650328680
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-05-30
• Public Version: 3
• Public Version Date: 2018-10-05
• Public Version Status: Update
• Public Device Record Key: eef49c58-7590-460d-a7d4-cb3ad86dd300

Device Description

MesireTM Latch - Catheter Holding System

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: No
• 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
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
48143	Paranasal sinus guide-catheter handle	A sterile, hand-held, tubular device designed to create an extension from which the user can stabilize the position of a sinus guide catheter. It typically has a malleable handle and a press-fit connector at the distal end for connection to the guide catheter. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	18904224905709	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K172737	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at or below 40°C; temperature