MEDLINE

Basic Information

• Brand Name: MEDLINE
• Primary DI: 10653160349402
• Version / Model: AVADIL9ST
• Catalog Number: AVADIL9ST
• Company Name: MEDLINE INDUSTRIES, INC.
• Labeler DUNS: 025460908
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-12-16
• Public Version: 1
• Public Version Date: 2021-12-24
• Public Version Status: New
• Public Device Record Key: dd0a3fa2-177a-4a0f-9a5b-1462fbf60d8d

Device Description

STERILE DILATOR, 9FR X 17.14CM

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: Yes
• PM Exempt: Yes
• 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
OFD	Catheter introducer kit	Cardiovascular	870.1340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38128	Vascular dilator, single-use	A sterile, hand-held, surgical instrument designed for insertion into a blood vessel (the vasculature) to unblock, enlarge or measure the internal diameter of the vessel during a surgical intervention. It is a rod-like device with a long, slender, body that terminates with a bulbous, cylindrical distal tip of various shapes and sizes. Commonly known as a vessel dilator or vascular probe, it is available in a variety of sizes (diameters and lengths) and flexibilities. It is typically made of metal or plastic materials. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00653160349405	GS1	CASE	50	In Commercial Distribution
Primary	10653160349402	GS1

Customer Contacts

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