Cross-Seal 002

GUDID 04719872920359

The Cross-Seal Device is composed of a Catheter, Suture Delivery System, and Handle. The Cross-Seal Device tracks over a standard 0.038” or 0.035” (minimum length 130 cm) guidewire. A hemostasis valve located in the middle of the CATHETER limits blood flow from the GUIDEWIRE PORT through the CATHETER with or without the guidewire in place. The SUTURE DELIVERY SYSTEM contains NEEDLES, LOCATOR WINGS, and the NEEDLE BARREL that control suture placement around the arteriotomy. The HANDLE contains the SLIDER, BLEEDING INDICATOR, PLUNGER, RESET 1 BUTTON (SLIDER RETRACTOR), and RESET 2 BUTTON (LOCATOR WINGS RETRACTOR). The SLIDER triggers a mechanism that opens the LOCATOR WINGS and creates a sandwich configuration to stabilize the delivery system within the vessel wall. The BLEEDING INDICATOR connects to a lumen that has an intraluminal port positioned at the distal end of the Suture Delivery System to allow bleeding back to ensure Suture Delivery System is positioned properly in the femoral artery. The NEEDLE BARREL keeps the Cross-Seal Device from moving deeper inside the vessel, stabilizes the device once the LOCATOR WINGS are opened and retrieves the disengaged suture-carried NEEDLES. The PLUNGER triggers the NEEDLES to deploy sutures and simultaneously close the LOCATOR WINGS. The GUIDEWIRE GUIDE is the feature at distal handle portion which allows physician to practice coaxial insertion of device along guidewire if necessary.

MEDEON BIODESIGN, INC.

Polyolefin suture, monofilament

• Primary Device ID: 04719872920359
• NIH Device Record Key: 21c59bfa-8df4-4d25-b6e9-2e5b30492849
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cross-Seal
• Version Model Number: 002
• Catalog Number: 002
• Company DUNS: 656078460
• Company Name: MEDEON BIODESIGN, INC.
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719872920359 [Primary]
GS1	04719872920366 [Package]; Package: Box [1 Units]; In Commercial Distribution
GS1	04719872920373 [Package]; Contains: 04719872920366; Package: Carton [12 Units]; In Commercial Distribution

FDA Product Code

• MGB: Device, Hemostasis, Vascular

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: 2022-02-09
• Device Publish Date: 2022-02-01

On-Brand Devices [Cross-Seal]

• 04719872920380: The Cross-Seal Accessories (Cross-Seal Knot Tyer, Cross-Seal Knot Pusher, and Cross-Seal Suture
• 04719872920359: The Cross-Seal Device is composed of a Catheter, Suture Delivery System, and Handle. The Cross-S