Graft Sizer Set

Basic Information

• Brand Name: Graft Sizer Set
• Primary DI: 05037881038919
• Version / Model: GSS002
• Catalog Number: GSS002
• Company Name: VASCUTEK LTD
• Labeler DUNS: 229053087
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 6
• Public Version Date: 2023-04-04
• Public Version Status: Update
• Public Device Record Key: 14542861-a699-4706-b49a-f17e408a2b5e
• Distribution End Date: 2020-07-14

Device Description

Graft Sizer Set

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: Yes
• 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: 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
DSY	PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER	Cardiovascular	870.3450	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44744	Open-surgery blood vessel sizer, single-use	A sterile, invasive instrument intended to be used during open vascular surgery to approximate the size of a blood vessel for selection of an appropriately sized vascular device/implant (e.g., vascular graft, emboli filter); it is not intended to obtain a precise measurement. The device typically consists of a C-shaped (half circle) sizing portion with a handle, sometimes available in a range of sizes, and is intended to size the outer diameter of the blood vessel (i.e., extraluminal sizing); it may in addition be used to size a vascular graft. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05037881038902	GS1		10	Not in Commercial Distribution	2020-07-14
Primary	05037881038919	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Size 5 - 38 mm

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a clean dry enviroment at normal room temperature