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 ID04719872920359
NIH Device Record Key21c59bfa-8df4-4d25-b6e9-2e5b30492849
Commercial Distribution StatusIn Commercial Distribution
Brand NameCross-Seal
Version Model Number002
Catalog Number002
Company DUNS656078460
Company NameMEDEON BIODESIGN, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104719872920359 [Primary]
GS104719872920366 [Package]
Package: Box [1 Units]
In Commercial Distribution
GS104719872920373 [Package]
Contains: 04719872920366
Package: Carton [12 Units]
In Commercial Distribution

FDA Product Code

MGBDevice, Hemostasis, Vascular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-09
Device Publish Date2022-02-01

On-Brand Devices [Cross-Seal]

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

Trademark Results [Cross-Seal]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CROSS-SEAL
CROSS-SEAL
88046024 not registered Live/Pending
Terumo Kabushiki Kaisha
2018-07-20
CROSS-SEAL
CROSS-SEAL
86940340 not registered Dead/Abandoned
SPC Resources, Inc.
2016-03-15

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