FOLLISTIM AQ CARTRIDGE 900IU

GUDID 60378206131012

Organon LLC

Autoinjector needle
Primary Device ID60378206131012
NIH Device Record Key952b2a4f-4a5d-43e7-bed3-df3d79f543e1
Commercial Distribution StatusIn Commercial Distribution
Brand NameFOLLISTIM AQ CARTRIDGE 900IU
Version Model Number1044617
Company DUNS117494753
Company NameOrganon LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Producttrue
Single Usetrue
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

Device Dimensions

Needle Gauge29 Gauge
Needle Gauge29 Gauge
Needle Gauge29 Gauge
Needle Gauge29 Gauge
Needle Gauge29 Gauge
Needle Gauge29 Gauge
Needle Gauge29 Gauge
Needle Gauge29 Gauge
Needle Gauge29 Gauge
Needle Gauge29 Gauge
Needle Gauge29 Gauge
Needle Gauge29 Gauge
Needle Gauge29 Gauge
Needle Gauge29 Gauge
Needle Gauge29 Gauge
Needle Gauge29 Gauge
Needle Gauge29 Gauge
Needle Gauge29 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
GS100378206131010 [Primary]
GS160378206131012 [Package]
Contains: 00378206131010
Package: box [24 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMINeedle, hypodermic, single lumen

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

10378206189018 - XACIATO2024-09-23
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
60378206131012 - FOLLISTIM AQ CARTRIDGE 900IU2024-01-09
60840164519442 - FOLLISTIM PEN STARTER KIT2024-01-09
60840164519459 - FOLLISTIM PEN STARTER KIT SAM2024-01-09

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