Omnitrope Pen 10

Basic Information

• Brand Name: Omnitrope Pen 10
• Primary DI: 57612799210546
• Version / Model: 49041459
• Company Name: Sandoz GmbH
• Labeler DUNS: 300220969
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-07
• Public Version: 5
• Public Version Date: 2025-05-09
• Public Version Status: Update
• Public Device Record Key: ec9efa49-3460-4fa9-bb09-885210b01193
• Distribution End Date: 2024-11-13

Device Description

The Omnitrope Pen 10 is a reusable injection pen for use with Omnitrope cartridges. Omnitrope Pen from BD is intended for subcutaneous injection of a daily dose of Omnitrope (rhGH drug). It is intended for patients (pediatric patients and adults) treated for growth disturbances and growth hormone deficiencies. The injection can be performed by the patient him/herself or also by a trained caregiver in case of small children or patients unable to perform the injection themselves. For information on the use of Omnitrope Pen 10, see: http://www.omnitrope.com/getting-started/injection-training/

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NSC	Injector, Pen	General Hospital	880.5860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45771	Empty self-injector, mechanical	A portable, hand-held, mechanical device, typically in the form of a large pen, designed to accept a pharmaceutical-containing cartridge (not included) and intended to be used by a patient or carer for subcutaneous or intramuscular injection of a dose of the pharmaceutical agent via a replaceable needle. A dial on the injector is operated for dosing (e.g., via a spring-loaded mechanism). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	47612799222856	GS1
Primary	57612799210546	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]