PreludeSYNC™

Basic Information

• Brand Name: PreludeSYNC™
• Primary DI: 10884450445201
• Version / Model: 10884450445201
• Catalog Number: SRB20EVOAC
• Company Name: Merit Medical Systems, Inc.
• Labeler DUNS: 184763290
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2019-10-03
• Public Version: 2
• Public Version Date: 2021-10-11
• Public Version Status: Update
• Public Device Record Key: c1b6e929-62d6-45f2-9312-cef857088180

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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
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
Primary	10884450445201	GS1
Unit of Use	00884450445204	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Size (Volume)-20 mL