Cook

Basic Information

• Brand Name: Cook
• Primary DI: 00827002146150
• Version / Model: G14615
• Catalog Number: 090021
• 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: b41ea085-b2b7-4204-8946-4060c7769e2b

Device Description

Disposable Two-Part Trocar Needle

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
FBQ	Trocar, gastro-urology	Gastroenterology, Urology	876.5090	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61503	Nephrostomy catheter introduction needle	A sterile, sharp bevel-edged, hollow tubular metal instrument designed to make the initial percutaneous puncture to access the kidney during nephrostomy catheter introduction for urinary drainage. It is intended to enable introduction of a guidewire (Seldinger technique); the therapeutic or diagnostic aspiration of fluids may be achieved during its placement. It may include an intraluminal stylet intended to add rigidity to the needle during introduction. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00827002146150	GS1

Customer Contacts

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

Storage Conditions

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