Dexterity Steerable Introducer

Basic Information

• Brand Name: Dexterity Steerable Introducer
• Primary DI: 00864795000139
• Version / Model: 14 Fr x 80 cm
• Catalog Number: 60-0007-25
• Company Name: PRIMO MEDICAL GROUP
• Labeler DUNS: 001064708
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-08
• Public Version: 1
• Public Version Date: 2023-12-18
• Public Version Status: New
• Public Device Record Key: c1b464da-fb17-47c1-ade7-50c052504291

Device Description

Finished Goods, Steerable Introducer, 14 Fr, 80CM - Dexterity

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DRA	Catheter, Steerable	Cardiovascular	870.1280	2
DYB	Introducer, Catheter	Cardiovascular	870.1340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47247	Cardiac transseptal access set	A collection of nonimplantable, invasive devices intended to be used to puncture the interatrial septum during a transseptal catheterization procedure, and to create a conduit for the introduction of various cardiovascular catheters into the left side of the heart. It includes a vascular guide-catheter (which may be referred to as a steerable introducer) with a transseptal needle to create the puncture, and typically includes additional introduction assistive devices necessary for the procedure (e.g., stylet, guidewire, dilator). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10864795000136	GS1	Shelf Carton	1	In Commercial Distribution
Primary	00864795000139	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K120086	000