Keller Funnel 2

Basic Information

• Brand Name: Keller Funnel 2
• Primary DI: 10888628043732
• Version / Model: HA-001
• Catalog Number: HA-001
• Company Name: Allergan, Inc.
• Labeler DUNS: 144796497
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-08
• Public Version: 1
• Public Version Date: 2022-12-16
• Public Version Status: New
• Public Device Record Key: 291e94d9-bce1-46fe-9291-84d0200878e4

Device Description

Silicone Breast Implant Insertion Device

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: No
• Has Manufacturing Date: No
• 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
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
59021	Breast implant delivery sleeve	A sterile flexible cylinder intended to assist with the delivery of a prefilled breast implant by providing a low-friction shell-tissue interface during implant insertion into a surgically-created breast pocket, without constricting the size of the implant. It is typically made of polyethylene (PE) plastic and is not intended to be used with a lubricant other than saline. The implant is directed through the tube by twisting of the distal end, or by direct manual manipulation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10888628043732	GS1

Customer Contacts

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