Cook

Basic Information

• Brand Name: Cook
• Primary DI: 00827002000728
• Version / Model: G00072
• Catalog Number: JCD6.3-38-20
• Company Name: COOK INCORPORATED
• Labeler DUNS: 042823948
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 404663ed-2f1d-4cc1-8e23-9ca12a9de43a

Device Description

Dilator

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: 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
DRE	DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION	Cardiovascular	870.1310	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46448	Fascial tissue dilator, single-use	A surgical instrument used for stretching or enlarging the fascial tissue covering a cavity, tract, or opening typically prior to the introduction of a catheter during an invasive diagnostic or interventional procedure (e.g., femoral artery catheterization). It is a rod-like device with a long, slender, hollow or solid body and a rounded nose, inflatable balloon or screw-tip at its distal end, that is available in a variety of sizes and typically made of metal or plastic. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00827002000728	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in dark, dry, cool place.