HEMOBLAST Bellows Laparoscopic Applicator LAP01-US

GUDID 03760193182668

HEMOBLAST Bellows Laparoscopic Applicator is intended for delivery of HEMOBLAST Bellows hemostatic powder to bleeding surgical sites through a 5mm or larger trocar.

DILON TECHNOLOGIES FRANCE

Collagen haemostatic agent, non-antimicrobial

• Primary Device ID: 03760193182668
• NIH Device Record Key: effcbdef-41a2-4b53-8317-d39f75af687e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HEMOBLAST Bellows Laparoscopic Applicator
• Version Model Number: LAP01-US
• Catalog Number: LAP01-US
• Company DUNS: 279346203
• Company Name: DILON TECHNOLOGIES FRANCE
• 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: true
• 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: +33486573610
• Email: contact@biomup.com
• Phone: +33486573610
• Email: contact@biomup.com
• Phone: +33486573610
• Email: contact@biomup.com
• Phone: +33486573610
• Email: contact@biomup.com
• Phone: +33486573610
• Email: contact@biomup.com
• Phone: +33486573610
• Email: contact@biomup.com
• Phone: +33486573610
• Email: contact@biomup.com
• Phone: +33486573610
• Email: contact@biomup.com
• Phone: +33486573610
• Email: contact@biomup.com
• Phone: +33486573610
• Email: contact@biomup.com
• Phone: +33486573610
• Email: contact@biomup.com
• Phone: +33486573610
• Email: contact@biomup.com
• Phone: +33486573610
• Email: contact@biomup.com
• Phone: +33486573610
• Email: contact@biomup.com
• Phone: +33486573610
• Email: contact@biomup.com
• Phone: +33486573610
• Email: contact@biomup.com
• Phone: +33486573610
• Email: contact@biomup.com
• Phone: 757-269-4910
• Email: info@dilon.com
• Phone: 757-269-4910
• Email: info@dilon.com
• Phone: 757-269-4910
• Email: info@dilon.com
• Phone: 757-269-4910
• Email: info@dilon.com
• Phone: 757-269-4910
• Email: info@dilon.com
• Phone: 757-269-4910
• Email: info@dilon.com
• Phone: 757-269-4910
• Email: info@dilon.com
• Phone: 757-269-4910
• Email: info@dilon.com
• Phone: 757-269-4910
• Email: info@dilon.com
• Phone: 757-269-4910
• Email: info@dilon.com
• Phone: 757-269-4910
• Email: info@dilon.com
• Phone: 757-269-4910
• Email: info@dilon.com
• Phone: 757-269-4910
• Email: info@dilon.com

Device Dimensions

• Length: 35 Centimeter
• Length: 35 Centimeter
• Length: 35 Centimeter
• Length: 35 Centimeter
• Length: 35 Centimeter
• Length: 35 Centimeter
• Length: 35 Centimeter
• Length: 35 Centimeter
• Length: 35 Centimeter
• Length: 35 Centimeter
• Length: 35 Centimeter
• Length: 35 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Dry Environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Dry Environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Dry Environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Dry Environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Dry Environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Dry Environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Dry Environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Dry Environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Dry Environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Dry Environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Dry Environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Dry Environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Dry Environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Dry Environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Dry Environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Dry Environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Dry Environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Dry Environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Dry Environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Dry Environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Dry Environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Dry Environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Dry Environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Dry Environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Dry Environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Dry Environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Dry Environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Dry Environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Dry Environment at room temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760193182668 [Primary]
GS1	13760193182665 [Package]; Contains: 23760193182662; Package: Carton [2 Units]; In Commercial Distribution
GS1	23760193182662 [Package]; Package: Box [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P170012

FDA Product Code

• PMX: Absorbable Collagen Hemostatic Agent With Thrombin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2023-10-04
• Device Publish Date: 2019-02-28

Devices Manufactured by DILON TECHNOLOGIES FRANCE

• 03760193181975 - SALVIN RENOVIX: 2023-10-04 Collagen Guided Healing Membrane
• 03760193181982 - SALVIN RENOVIX: 2023-10-04 Collagen Guided Healing Membrane
• 03760193181999 - SALVIN RENOVIX: 2023-10-04 Collagen Guided Healing Membrane
• 03760193182019 - COVAORTHO-NERVE: 2023-10-04 Collagen Guided Healing Membrane
• 03760193182026 - COVAORTHO-NERVE: 2023-10-04 Collagen Guided Healing Membrane
• 03760193182033 - COVAORTHO-NERVE: 2023-10-04 Collagen Guided Healing Membrane
• 03760193182040 - COVAORTHO-NERVE: 2023-10-04 Collagen Guided Healing Membrane
• 03760193182057 - COVAORTHO-NERVE: 2023-10-04 Collagen Guided Healing Membrane