EndoClot Applicator

GUDID 46972011720111

EndoClot Plus Co.,Ltd.

Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-use Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-use Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-use Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-use Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-use Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-use Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-use Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-use Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-use Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-use Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-use Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-use Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-use Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-use Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-use Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-use

• Primary Device ID: 46972011720111
• NIH Device Record Key: f3258f82-9a8a-4878-918f-df68728bde74
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EndoClot Applicator
• Version Model Number: EA230
• Company DUNS: 544357082
• Company Name: EndoClot Plus Co.,Ltd.
• 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: false
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	16972011720110 [Primary]
GS1	46972011720111 [Package]; Contains: 16972011720110; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162197

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

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: 2021-07-01
• Device Publish Date: 2021-06-23

Devices Manufactured by EndoClot Plus Co.,Ltd.

• 26972011720513 - EndoClot: 2022-03-28 EndoClot® Air Compressor Connecting Tube
• 26972011720018 - EndoClot: 2022-03-23 EndoClot®Polysaccharide Hemostatic System, EndoClot® PHS
• 26972011720247 - EndoClot SIS: 2021-11-24 EndoClot Submucosal Injection System
• 26972011720254 - EndoClot SIS: 2021-11-24 EndoClot Submucosal Injection System
• 26972011720025 - EndoClot PHS: 2021-07-01
• 26972011720032 - EndoClot PHS: 2021-07-01
• 46972011720111 - EndoClot Applicator: 2021-07-01
• 46972011720111 - EndoClot Applicator: 2021-07-01
• 26972011720223 - EndoClot: 2021-07-01