Prelude SNAP 165™

Basic Information

• Brand Name: Prelude SNAP 165™
• Primary DI: 10884450484491
• Version / Model: 10884450484491
• Catalog Number: PLS165/A
• Company Name: Merit Medical Systems, Inc.
• Labeler DUNS: 184763290
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2020-12-03
• Public Version: 1
• Public Version Date: 2020-12-11
• Public Version Status: New
• Public Device Record Key: 32638fe0-181b-4d07-898f-921b9bf8f104

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• 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
KGZ	ACCESSORIES, CATHETER	General, Plastic Surgery	878.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62391	Non-vascular catheter introduction set	A collection of sterile, invasive devices intended to enable percutaneous Seldinger-type introduction of a non-vascular catheter (e.g., drainage catheter) into a body cavity or lumen (e.g., biliary tract, ureter); it is not intended for introduction of a peritoneal dialysis catheter. It includes multiple invasive access devices which typically include an introducer needle, introducer sheath with an inner dilator, and guidewire; the catheter is not included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00884450484494	GS1
Primary	10884450484491	GS1