Cook

Basic Information

• Brand Name: Cook
• Primary DI: 00827002172180
• Version / Model: G17218
• Catalog Number: J-SPD-003000
• 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: d93408b1-cc9f-4e95-a1ff-d8781e1b32df

Device Description

Silicone Penrose Drain

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
GCY	APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED	General, Plastic Surgery	878.4680	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43437	Surgical capillary wound drain, luminal, synthetic polymer	A sterile device with a lumen(s) designed to establish a passive egress for the removal of fluid (drainage of blood, lymph, exudate) from a surgical wound to minimize its accumulation and risk of wound infection; it is not dedicated to a particular anatomical wound. It is typically inserted into the wound by a surgeon in the operating room (OR) after the completion of an inpatient or outpatient procedure. It is typically made of radiopaque silicone and is available in various forms (e.g., Penrose type, tubular with side holes, multi-tubular). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00827002172180	GS1

Customer Contacts

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

Storage Conditions

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