PreludeSYNC™

Basic Information

• Brand Name: PreludeSYNC™
• Primary DI: 10884450358945
• Version / Model: 10884450358945
• Catalog Number: SRB-00002
• Company Name: Merit Medical Systems, Inc.
• Labeler DUNS: 184763290
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2018-03-01
• Public Version: 3
• Public Version Date: 2021-10-11
• Public Version Status: Update
• Public Device Record Key: fa5b3c84-ea97-433b-8b0f-cf2d4fd9fdde

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: 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
DXC	CLAMP, VASCULAR	Cardiovascular	870.4450	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17718	Vascular compressor, external	A thin, gently curved sheet of radiolucent plastic used for external compression of the internal spermatic vein to prevent distal flow of a sclerosing agent. The device is also used in the compression of additional veins, bypass grafts, and fistulas during angiographic procedures. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20884450358942	GS1		4	In Commercial Distribution
Primary	10884450358945	GS1
Unit of Use	00884450358948	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Band Length-24 cm