FOLLISTIM PEN STARTER KIT SAM

GUDID 60840164519459

Organon LLC

Cartridge-accepting autoinjector, mechanical Cartridge-accepting autoinjector, mechanical Cartridge-accepting autoinjector, mechanical Cartridge-accepting autoinjector, mechanical Cartridge-accepting autoinjector, mechanical Cartridge-accepting autoinjector, mechanical Cartridge-accepting autoinjector, mechanical Cartridge-accepting autoinjector, mechanical Cartridge-accepting autoinjector, mechanical Cartridge-accepting autoinjector, mechanical Cartridge-accepting autoinjector, mechanical Cartridge-accepting autoinjector, mechanical Cartridge-accepting autoinjector, mechanical Cartridge-accepting autoinjector, mechanical Cartridge-accepting autoinjector, mechanical Cartridge-accepting autoinjector, mechanical Cartridge-accepting autoinjector, mechanical Cartridge-accepting autoinjector, mechanical Empty self-injector, mechanical Empty self-injector, mechanical Empty self-injector, mechanical Empty self-injector, mechanical Empty self-injector, mechanical Empty self-injector, mechanical Empty self-injector, mechanical Empty self-injector, mechanical Empty self-injector, mechanical Empty self-injector, mechanical Empty self-injector, mechanical Empty self-injector, mechanical Empty self-injector, mechanical Empty self-injector, mechanical
Primary Device ID60840164519459
NIH Device Record Key9d7259c2-bbd2-4caf-813a-e8a06c6ce127
Commercial Distribution StatusIn Commercial Distribution
Brand NameFOLLISTIM PEN STARTER KIT SAM
Version Model Number1044943
Company DUNS117494753
Company NameOrganon LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Producttrue
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(844)674-3200
Emaildpoc.us@organon.com
Phone+1(844)674-3200
Emaildpoc.us@organon.com
Phone+1(844)674-3200
Emaildpoc.us@organon.com
Phone+1(844)674-3200
Emaildpoc.us@organon.com
Phone+1(844)674-3200
Emaildpoc.us@organon.com
Phone+1(844)674-3200
Emaildpoc.us@organon.com
Phone+1(844)674-3200
Emaildpoc.us@organon.com
Phone+1(844)674-3200
Emaildpoc.us@organon.com
Phone+1(844)674-3200
Emaildpoc.us@organon.com
Phone+1(844)674-3200
Emaildpoc.us@organon.com
Phone+1(844)674-3200
Emaildpoc.us@organon.com
Phone+1(844)674-3200
Emaildpoc.us@organon.com
Phone+1(844)674-3200
Emaildpoc.us@organon.com
Phone+1(844)674-3200
Emaildpoc.us@organon.com
Phone+1(844)674-3200
Emaildpoc.us@organon.com
Phone+1(844)674-3200
Emaildpoc.us@organon.com
Phone+1(844)674-3200
Emaildpoc.us@organon.com
Phone+1(844)674-3200
Emaildpoc.us@organon.com
Phone+1(844)674-3200
Emaildpoc.us@organon.com
Phone+1(844)674-3200
Emaildpoc.us@organon.com
Phone+1(844)674-3200
Emaildpoc.us@organon.com
Phone+1(844)674-3200
Emaildpoc.us@organon.com
Phone+1(844)674-3200
Emaildpoc.us@organon.com
Phone+1(844)674-3200
Emaildpoc.us@organon.com
Phone+1(844)674-3200
Emaildpoc.us@organon.com
Phone+1(844)674-3200
Emaildpoc.us@organon.com
Phone+1(844)674-3200
Emaildpoc.us@organon.com
Phone+1(844)674-3200
Emaildpoc.us@organon.com
Phone+1(844)674-3200
Emaildpoc.us@organon.com
Phone+1(844)674-3200
Emaildpoc.us@organon.com
Phone+1(844)674-3200
Emaildpoc.us@organon.com
Phone+1(844)674-3200
Emaildpoc.us@organon.com

Device Dimensions

Length6.25 Inch
Length6.25 Inch
Length6.25 Inch
Length6.25 Inch
Length6.25 Inch
Length6.25 Inch
Length6.25 Inch
Length6.25 Inch
Length6.25 Inch
Length6.25 Inch
Length6.25 Inch
Length6.25 Inch
Length6.25 Inch
Length6.25 Inch
Length6.25 Inch
Length6.25 Inch
Length6.25 Inch
Length6.25 Inch
Length6.25 Inch
Length6.25 Inch
Length6.25 Inch
Length6.25 Inch
Length6.25 Inch
Length6.25 Inch
Length6.25 Inch
Length6.25 Inch
Length6.25 Inch
Length6.25 Inch
Length6.25 Inch
Length6.25 Inch
Length6.25 Inch
Length6.25 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100840164519457 [Primary]
GS160840164519459 [Package]
Contains: 00840164519457
Package: box [12 Units]
In Commercial Distribution

FDA Product Code

NSCINJECTOR, PEN

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-09
Device Publish Date2024-01-01

Devices Manufactured by Organon LLC

60378206129019 - FOLLISTIM AQ CARTRIDGE 300IU2024-01-09
60378206129590 - FOLLISTIM AQ CARTRIDGE 300IU SAM2024-01-09
60378206130015 - FOLLISTIM AQ CARTRIDGE 600IU2024-01-09
60378206130596 - FOLLISTIM AQ CARTRIDGE 600IU SAM2024-01-09
60378206131012 - FOLLISTIM AQ CARTRIDGE 900IU2024-01-09
60840164519442 - FOLLISTIM PEN STARTER KIT2024-01-09
60840164519459 - FOLLISTIM PEN STARTER KIT SAM2024-01-09
60840164519459 - FOLLISTIM PEN STARTER KIT SAM2024-01-09
60840164521131 - JADA System2023-02-23 Vacuum-induced Hemorrhage Control System

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.