XACIATO

GUDID 10378206189018

Organon LLC

Vaginal applicator, single-use

• Primary Device ID: 10378206189018
• NIH Device Record Key: 2cf3bd9f-d53b-47bc-af99-432d3e2a1217
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XACIATO
• Version Model Number: 1048228
• Company DUNS: 117494753
• Company Name: Organon LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: true
• Single Use: true
• 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

Device Dimensions

• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram
• Weight: 5 Gram

Device Identifiers

Device Issuing Agency	Device ID
GS1	10378206189018 [Primary]

FDA Product Code

• HGD: APPLICATOR, VAGINAL

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-23
• Device Publish Date: 2024-09-13

Devices Manufactured by Organon LLC

• 10378206189018 - XACIATO: 2024-09-23
• 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
• 60840164519459 - FOLLISTIM PEN STARTER KIT SAM: 2024-01-09