MicroIntroducer 3Fr x 7cm ELITE HV CLI-136-00

GUDID 20841268108435

MicroIntroducer 3Fr x 7cm ELITE HV

GALT MEDICAL CORP.

Haemostasis valve

• Primary Device ID: 20841268108435
• NIH Device Record Key: 86008381-8ea2-4dcd-95e8-f429b4c65e51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MicroIntroducer 3Fr x 7cm ELITE HV
• Version Model Number: CLI-136-00
• Catalog Number: CLI-136-00
• Company DUNS: 943156836
• Company Name: GALT MEDICAL CORP.
• Device Count: 1
• DM Exempt: false
• 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: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-639-2800
• Email: customerservice@galtneedletech.com

Device Dimensions

• Catheter Gauge: 3 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841268108431 [Primary]
GS1	10841268108438 [Package]; Contains: 00841268108431; Package: Shelf Box [10 Units]; In Commercial Distribution
GS1	20841268108435 [Package]; Contains: 10841268108438; Package: Shipper Box [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043525

FDA Product Code

• DYB: Introducer, Catheter

Sterilization

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

[20841268108435]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-03-05
• Device Publish Date: 2019-05-23

Devices Manufactured by GALT MEDICAL CORP.

• 10841268109800 - Elite Transitionless Micro-Introducer Kit: 2022-08-23 Elite Transitionless Micro-Introducer Kit
• 10841268109817 - Elite Transitionless Micro-Introducer Kit: 2022-08-23 Elite Transitionless Micro-Introducer Kit
• 10841268109824 - Elite Transitionless Micro-Introducer Kit: 2022-08-23 Elite Transitionless Micro-Introducer Kit
• 10841268109831 - Elite Transitionless Micro-Introducer Kit: 2022-08-23 Elite Transitionless Micro-Introducer Kit
• 10841268109848 - Elite Transitionless Micro-Introducer Kit: 2022-08-23 Elite Transitionless Micro-Introducer Kit
• 10841268109855 - Elite Transitionless Micro-Introducer Kit: 2022-08-23 Elite Transitionless Micro-Introducer Kit
• 10841268109862 - Elite Transitionless Micro-Introducer Kit: 2022-08-23 Elite Transitionless Micro-Introducer Kit
• 10841268109879 - Elite Transitionless Micro-Introducer Kit: 2022-08-23 Elite Transitionless Micro-Introducer Kit