Cook

Basic Information

• Brand Name: Cook
• Primary DI: 00827002164048
• Version / Model: G16404
• Catalog Number: J-DTCA-103007
• Company Name: COOK INCORPORATED
• Labeler DUNS: 042823948
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-10-02
• Public Version: 1
• Public Version Date: 2020-10-12
• Public Version Status: New
• Public Device Record Key: 7b36ae6b-9b47-44c3-ad6c-a17b27f041e3

Device Description

Disposable Topel Endoscopic Cyst Aspirator 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: 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
GAA	NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47994	Endoscopic cyst-aspiration set	A collection of sterile devices designed to stabilize and aspirate a cyst or other internal anatomical structure under direct endoscopic vision during a surgical procedure, typically enabling aspiration of fluid without leakage into the surrounding anatomy (e.g., the peritoneal cavity). It typically consists of a long, slender, sharply-pointed, metal needle (e.g., stainless steel) within an aspiration tube [e.g., stainless steel or polycarbonate (PC)] that is applied to the lesion with suction; it may include adaptors and tubing to connect to the source of suction. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00827002164048	GS1

Customer Contacts

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

Storage Conditions

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