Orbit Inserter

Basic Information

• Brand Name: Orbit Inserter
• Primary DI: 00850037806058
• Version / Model: MODD1 Insulin Delivery System
• Catalog Number: MTL-46
• Company Name: Modular Medical, Inc.
• Labeler DUNS: 602638525
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-07-11
• Public Version: 1
• Public Version Date: 2025-07-21
• Public Version Status: New
• Public Device Record Key: 1441b426-0da1-4355-86e5-cbfac4215ebc

Device Description

Box of one (1) Infusion Set Inserter

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• 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
KZH	Introducer, Syringe Needle	General Hospital	880.6920	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60415	Insulin infusion cannula introducer	A non-sterile, hand-held, mechanical device intended to aid introduction of a cannula/needle subcutaneously into fatty tissue for use with an insulin infusion pump. It typically consists of a small housing that chambers the cannula and a triggered release mechanism for automated insertion of the cannula/needle into tissues. It is intended for use in the home. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850037806058	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K163400	000