What is FDA product code NSC?

A pen injector is a device that provides a nonelectrically-powered, mechanically-operated method of accurately injecting a dose of medicinal product from a medicinal cartridge, reservoir, or syringe through a manually-inserted single lumen hypodermic needle. The device can be used by health professionals or for self-injection by the patient.

General Hospital › TherapeuticInjector, Pen

Follistim PEN Starter KIT SAM

Name: Follistim PEN Starter KIT SAM
Brand: Follistim PEN Starter KIT SAM

Catalogue number 1044943, listed by Organon LLC, United States, under Injector, Pen. 2 manufacturers in China are registered for this product code.

Registry build 21.09.26

2manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Zhejiang (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code NSC
Manufacturer	City	Province	Registered as	Device types
Sanmina	Kunshan	Jiangsu	Contract manufacturer	15
Promisemed Hangzhou Meditech Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	21

Record

Regulatory record for Follistim PEN Starter KIT SAM
Listed by	Organon LLC, United States
FDA product code	NSC
Device type	Injector, Pen
Device class	Class 2
Regulation	21 CFR 880.5860
Establishment	Specification developer, Manufacturer
Premarket notification	Exempt
Record published	2024-01-01
Record revised	2024-04-03 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date, serial number
Packaging	Box of 12
Sizes	Length 6.25 in

Catalogue Numbers

Catalogue numbers for Follistim PEN Starter KIT SAM
Catalogue number	Size	Status
1044943	Length 6.25 in	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Omnitrope Pen 10	Sandoz GmbH	2
Omnitrope® Pen 5	Sandoz GmbH	2
Follistim PEN Starter KIT	Organon LLC	1
AutoTouch Connect reusable autoinjector	Amgen, Inc.	1
Follistim PEN Starter KIT SAM USA	Merck, Sharp & Dohme	1
Genotropin Pen® 5	Pharmacia & Upjohn Company LLC	1
Follistim PEN Starter KIT USA	Merck, Sharp & Dohme	1
Genotropin Pen® 12	Pharmacia & Upjohn Company LLC	1
AutoTouch reusable autoinjector	Amgen, Inc.	1

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.