Cadence ™ Precision Injector Thread 1 mL Syringe

Basic Information

• Brand Name: Cadence ™ Precision Injector Thread 1 mL Syringe
• Primary DI: 20763000293424
• Version / Model: 103-0304
• Company Name: Micro Therapeutics, Inc.
• Labeler DUNS: 826110710
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2022-12-23
• Public Version: 1
• Public Version Date: 2023-01-02
• Public Version Status: New
• Public Device Record Key: ba5c50bd-6952-453c-badd-c82af94088c9

Device Description

INJECTOR 103-0304 V02 CADENCE BOX MDR

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MJN	Catheter, intravascular occluding, temporary	Cardiovascular	870.4450	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17541	Catheter/overtube balloon inflator, single-use	A device designed to inflate and regulate the pressure of the balloon of a catheter, endoscopic overtube, or other invasive device (e.g., tamp, endomicroscopy probe), typically by injecting and aspirating fluid or air within the balloon, and to deflate the balloon during a medical procedure. It typically consists of a dedicated manual syringe/plunger or electronic mechanism for inflation/deflation, an analogue or digital gauge/screen for monitoring pressure, a locking mechanism, and a connecting tube. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00763000293420	GS1
Primary	20763000293424	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K011535	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a dry place, away from sunlight.