Dexterity Steerable Introducer 60-0031-20

GUDID 10864795000105

FG 9Fr Dexterity Introducer 75cm 2-0 Tip

PRIMO MEDICAL GROUP

Cardiac transseptal access set

• Primary Device ID: 10864795000105
• NIH Device Record Key: ff5468a6-0fd3-4163-85bb-4d97d9e47a5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dexterity Steerable Introducer
• Version Model Number: 9 Fr x 75 cm
• Catalog Number: 60-0031-20
• Company DUNS: 001064708
• Company Name: PRIMO MEDICAL GROUP
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 781-828-4400
• Email: Quality@PrimoMedicalGroup.com
• Phone: 781-828-4400
• Email: Quality@PrimoMedicalGroup.com
• Phone: 781-828-4400
• Email: Quality@PrimoMedicalGroup.com
• Phone: 781-828-4400
• Email: Quality@PrimoMedicalGroup.com
• Phone: 781-828-4400
• Email: Quality@PrimoMedicalGroup.com
• Phone: 781-828-4400
• Email: Quality@PrimoMedicalGroup.com
• Phone: 781-828-4400
• Email: Quality@PrimoMedicalGroup.com
• Phone: 781-828-4400
• Email: Quality@PrimoMedicalGroup.com
• Phone: 781-828-4400
• Email: Quality@PrimoMedicalGroup.com
• Phone: 781-828-4400
• Email: Quality@PrimoMedicalGroup.com
• Phone: 781-828-4400
• Email: Quality@PrimoMedicalGroup.com
• Phone: 781-828-4400
• Email: Quality@PrimoMedicalGroup.com
• Phone: 781-828-4400
• Email: Quality@PrimoMedicalGroup.com
• Phone: 781-828-4400
• Email: Quality@PrimoMedicalGroup.com
• Phone: 781-828-4400
• Email: Quality@PrimoMedicalGroup.com
• Phone: 781-828-4400
• Email: Quality@PrimoMedicalGroup.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00864795000108 [Primary]
GS1	10864795000105 [Package]; Contains: 00864795000108; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120086

FDA Product Code

• DRA: Catheter, Steerable

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-18
• Device Publish Date: 2023-12-08

On-Brand Devices [Dexterity Steerable Introducer]

• 10864795000136: Finished Goods, Steerable Introducer, 14 Fr, 80CM - Dexterity
• 10864795000105: FG 9Fr Dexterity Introducer 75cm 2-0 Tip