Elite HV Transitionless Hemostasis Valve Introducer Kit CLI-127-07

GUDID 20841268103898

Elite HV Transitionless Hemostasis Valve Introducer Kit

GALT MEDICAL CORP.

Haemostasis valve

• Primary Device ID: 20841268103898
• NIH Device Record Key: b8cb8702-01df-464d-bf18-5869794e734b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elite HV Transitionless Hemostasis Valve Introducer Kit
• Version Model Number: CLI-127-07
• Catalog Number: CLI-127-07
• 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: 7 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841268103894 [Primary]
GS1	10841268103891 [Package]; Contains: 00841268103894; Package: Shelf Box [5 Units]; In Commercial Distribution
GS1	20841268103898 [Package]; Contains: 10841268103891; Package: Shipper Box [50 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

[20841268103898]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-03-05
• Device Publish Date: 2018-03-01

On-Brand Devices [Elite HV Transitionless Hemostasis Valve Introducer Kit]

• 20841268108893: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268108886: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268108879: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268108862: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103959: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103942: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103935: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103928: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103911: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103904: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103898: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103881: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103874: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103867: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103850: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103843: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103836: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103829: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103812: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103805: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103799: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103782: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103775: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103768: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103751: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103744: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103737: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103720: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103713: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103706: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103690: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103683: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103676: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103669: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103652: Elite HV Transitionless Hemostasis Valve Introducer Kits
• 20841268103645: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103638: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103621: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103614: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103607: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103591: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103584: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103577: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 20841268103560: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 10841268109022: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 10841268109015: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 10841268109008: Elite HV Transitionless Hemostasis Valve Introducer Kit
• 10841268108995: Elite HV Transitionless Hemostasis Valve Introducer Kit