Cook

Basic Information

• Brand Name: Cook
• Primary DI: 00827002352155
• Version / Model: G35215
• Catalog Number: BBFS-100-MS
• 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: 484527a3-25b7-44ec-9609-f2e0c4ef69c0

Device Description

Transluminal Biliary Biopsy Forceps 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
FCL	FORCEPS, BIOPSY, NON-ELECTRIC	Gastroenterology, Urology	876.1075	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60378	Percutaneous biliary biopsy procedure kit	A collection of sterile devices intended to be used to obtain a tissue specimen from within the biliary duct system for histological analysis by a percutaneous approach, typically under fluoroscopic visualization. It typically includes flexible biopsy forceps consisting of a handle, shaft, and a standard cup for tissue sampling, and various devices required for access [e.g., needle(s), introducer(s), guidewire(s) and catheter(s)]. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00827002352155	GS1

Customer Contacts

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

Storage Conditions

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