COOK

Basic Information

• Brand Name: COOK
• Primary DI: 00827002475557
• Version / Model: G47555
• Catalog Number: PMG-18-90-COPE-NT-FTC
• Company Name: COOK INCORPORATED
• Labeler DUNS: 042823948
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-06
• Public Version: 1
• Public Version Date: 2019-03-14
• Public Version Status: New
• Public Device Record Key: d26b09ff-bb76-45bb-ab18-86a7556a415c

Device Description

Cook Fallopian Tube Catheterization Wire Guide with Platinum Tip

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: 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
LKF	Cannula, manipulator/injector, uterine	Obstetrics/Gynecology	884.4530	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63818	Fallopian tube guidewire	A sterile flexible wire intended to be inserted through the working channel/lumen of a compatible uterine access device (e.g., balloon catheter, hysteroscope) to facilitate introduction of a catheter for subsequent injection of a dye or contrast medium for the evaluation of tubal patency. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00827002475557	GS1

Customer Contacts

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

Storage Conditions

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