NobleStitch EL

GUDID M705129007

The NobleStitch™ EL system deploys suture to close an open tissue site in the cardiovascular system, including Patent Foramen Ovale (PFO) closure. The NobleStitch™ EL system consists of two suture delivery devices (one identified as ‘S’, and one identified as ‘P’), and one accessory knot delivery device (identified as ‘KwiKnot™’). The devices work in harmony with each other to place sutures and a knot at the closure site. Also included with the system are other accessories that aid the user in the operation of the devices (accessories may vary). The NobleStitch™ EL suture delivery devices each utilize an arm that is preloaded with 4-0 non-absorbable polypropylene monofilament suture. The NobleStitch™ EL knot delivery ‘KwiKnot™’ device is preloaded with a non-absorbable polypropylene radiopaque knot. The devices do not require any suture or knot loading/manipulation prior to use. The NobleStitch™ EL system operates in the following manner: When a suture end is positioned by the NobleStitch™ EL S suture delivery device arm, a needle is deployed from the device; the deployed needle pierces the closure site tissue and engages the suture end located in the device arm. As the needle is then withdrawn from the arm it captures and retains the suture end. The retained suture end is drawn through the tissue and is retained at the tip of the retracted needle until removed by the user at the appropriate time. The opposite end of the same suture is then free to be removed from the device. The same process is then repeated for a second suture using the NobleStitch™ EL P suture delivery device. Both placed sutures (a total of four suture ends) are then threaded through the KwiKnot™ device. The KwiKnot™ device delivers and engages a two-piece knot to secure the suture at the closure site.

Heartstitch, Inc.

Suturing unit, single-use

• Primary Device ID: M705129007
• NIH Device Record Key: d74e082c-0ee4-40a4-8017-68951ffd838b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NobleStitch EL
• Version Model Number: 12-90-07
• Company DUNS: 080248116
• Company Name: Heartstitch, Inc.
• 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: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +17144276348
• Email: info@heartstitch.com
• Phone: +17144276348
• Email: info@heartstitch.com
• Phone: +17144276348
• Email: info@heartstitch.com
• Phone: +17144276348
• Email: info@heartstitch.com
• Phone: +17144276348
• Email: info@heartstitch.com
• Phone: +17144276348
• Email: info@heartstitch.com
• Phone: +17144276348
• Email: info@heartstitch.com
• Phone: +17144276348
• Email: info@heartstitch.com
• Phone: +17144276348
• Email: info@heartstitch.com
• Phone: +17144276348
• Email: info@heartstitch.com
• Phone: +17144276348
• Email: info@heartstitch.com
• Phone: +17144276348
• Email: info@heartstitch.com

Device Dimensions

• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French

Operating and Storage Conditions

• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M705129007 [Primary]

FDA Product Code

• HCF: Instrument, Ligature Passing And Knot Tying

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: 2023-06-02
• Device Publish Date: 2023-05-25