FOLLISTIM PEN STARTER KIT

Basic Information

• Brand Name: FOLLISTIM PEN STARTER KIT
• Primary DI: 00840164519440
• Version / Model: 1044942
• Company Name: Organon LLC
• Labeler DUNS: 117494753
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-01-01
• Public Version: 1
• Public Version Date: 2024-01-09
• Public Version Status: New
• Public Device Record Key: 6102d10c-51a0-4b19-ae75-3531ff1c5d68

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: Yes
• 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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• 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
NSC	INJECTOR, PEN	General Hospital	880.5860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45771	Cartridge-accepting autoinjector, mechanical	A portable, hand-held, mechanical device, typically in the form of a large pen, designed to accept a pharmaceutical-containing cartridge (not included) and intended to be used by a patient to subcutaneously inject a dose of the pharmaceutical agent via a replaceable needle. The cartridge is inserted into the device and typically a dial on the device is operated for dosing (e.g., via a spring-loaded mechanism); the cartridge is replaced once the pharmaceutical is exhausted. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	60840164519442	GS1	box	12	In Commercial Distribution
Primary	00840164519440	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K162516	000

Device Sizes

Type	Value	Unit	Text
Length	6.25	Inch