FOLLISTIM PEN STARTER KIT

GUDID 60840164519442

Organon LLC

Cartridge-accepting autoinjector, mechanical

• Primary Device ID: 60840164519442
• NIH Device Record Key: 6102d10c-51a0-4b19-ae75-3531ff1c5d68
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FOLLISTIM PEN STARTER KIT
• Version Model Number: 1044942
• Company DUNS: 117494753
• Company Name: Organon LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: true
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(844)674-3200
• Email: dpoc.us@organon.com
• Phone: +1(844)674-3200
• Email: dpoc.us@organon.com
• Phone: +1(844)674-3200
• Email: dpoc.us@organon.com
• Phone: +1(844)674-3200
• Email: dpoc.us@organon.com
• Phone: +1(844)674-3200
• Email: dpoc.us@organon.com
• Phone: +1(844)674-3200
• Email: dpoc.us@organon.com
• Phone: +1(844)674-3200
• Email: dpoc.us@organon.com
• Phone: +1(844)674-3200
• Email: dpoc.us@organon.com
• Phone: +1(844)674-3200
• Email: dpoc.us@organon.com
• Phone: +1(844)674-3200
• Email: dpoc.us@organon.com
• Phone: +1(844)674-3200
• Email: dpoc.us@organon.com
• Phone: +1(844)674-3200
• Email: dpoc.us@organon.com
• Phone: +1(844)674-3200
• Email: dpoc.us@organon.com
• Phone: +1(844)674-3200
• Email: dpoc.us@organon.com
• Phone: +1(844)674-3200
• Email: dpoc.us@organon.com
• Phone: +1(844)674-3200
• Email: dpoc.us@organon.com
• Phone: +1(844)674-3200
• Email: dpoc.us@organon.com
• Phone: +1(844)674-3200
• Email: dpoc.us@organon.com
• Phone: +1(844)674-3200
• Email: dpoc.us@organon.com
• Phone: +1(844)674-3200
• Email: dpoc.us@organon.com
• Phone: +1(844)674-3200
• Email: dpoc.us@organon.com
• Phone: +1(844)674-3200
• Email: dpoc.us@organon.com
• Phone: +1(844)674-3200
• Email: dpoc.us@organon.com
• Phone: +1(844)674-3200
• Email: dpoc.us@organon.com
• Phone: +1(844)674-3200
• Email: dpoc.us@organon.com
• Phone: +1(844)674-3200
• Email: dpoc.us@organon.com
• Phone: +1(844)674-3200
• Email: dpoc.us@organon.com
• Phone: +1(844)674-3200
• Email: dpoc.us@organon.com
• Phone: +1(844)674-3200
• Email: dpoc.us@organon.com
• Phone: +1(844)674-3200
• Email: dpoc.us@organon.com
• Phone: +1(844)674-3200
• Email: dpoc.us@organon.com
• Phone: +1(844)674-3200
• Email: dpoc.us@organon.com

Device Dimensions

• Length: 6.25 Inch
• Length: 6.25 Inch
• Length: 6.25 Inch
• Length: 6.25 Inch
• Length: 6.25 Inch
• Length: 6.25 Inch
• Length: 6.25 Inch
• Length: 6.25 Inch
• Length: 6.25 Inch
• Length: 6.25 Inch
• Length: 6.25 Inch
• Length: 6.25 Inch
• Length: 6.25 Inch
• Length: 6.25 Inch
• Length: 6.25 Inch
• Length: 6.25 Inch
• Length: 6.25 Inch
• Length: 6.25 Inch
• Length: 6.25 Inch
• Length: 6.25 Inch
• Length: 6.25 Inch
• Length: 6.25 Inch
• Length: 6.25 Inch
• Length: 6.25 Inch
• Length: 6.25 Inch
• Length: 6.25 Inch
• Length: 6.25 Inch
• Length: 6.25 Inch
• Length: 6.25 Inch
• Length: 6.25 Inch
• Length: 6.25 Inch
• Length: 6.25 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840164519440 [Primary]
GS1	60840164519442 [Package]; Contains: 00840164519440; Package: box [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162516

FDA Product Code

• NSC: INJECTOR, PEN

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-09
• Device Publish Date: 2024-01-01

Devices Manufactured by Organon LLC

• 10378206189018 - XACIATO: 2024-09-23
• 60378206129019 - FOLLISTIM AQ CARTRIDGE 300IU: 2024-01-09
• 60378206129590 - FOLLISTIM AQ CARTRIDGE 300IU SAM: 2024-01-09
• 60378206130015 - FOLLISTIM AQ CARTRIDGE 600IU: 2024-01-09
• 60378206130596 - FOLLISTIM AQ CARTRIDGE 600IU SAM: 2024-01-09
• 60378206131012 - FOLLISTIM AQ CARTRIDGE 900IU: 2024-01-09
• 60840164519442 - FOLLISTIM PEN STARTER KIT: 2024-01-09
• 60840164519442 - FOLLISTIM PEN STARTER KIT: 2024-01-09
• 60840164519459 - FOLLISTIM PEN STARTER KIT SAM: 2024-01-09