ACTEON 246200

GUDID 03760243000959

HEMOSTASYL is a paste to be used as a haemostatic dressing with a mechanical action. Kit containing: 2 x 2g syringes of HEMOSTASYL Paste (about 30 uses) and 40 HEMOSTASYL angled application cannulas. Syringe for multiple uses. Application cannulas for single use.

PRODUITS DENTAIRES PIERRE ROLLAN

Inorganic haemostatic agent, non-sterile

• Primary Device ID: 03760243000959
• NIH Device Record Key: c4f10845-6278-49b2-b5e1-8976c5d89214
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACTEON
• Version Model Number: Hemostasyl Kit
• Catalog Number: 246200
• Company DUNS: 277657631
• Company Name: PRODUITS DENTAIRES PIERRE ROLLAN
• 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: false
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760243000959 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082116

FDA Product Code

• MVL: Cord, Retraction

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-12
• Device Publish Date: 2020-03-04

On-Brand Devices [ACTEON]

• 03760243001048: Expasyl is a paste for temporary gingival retraction that ensures separation of the marginal gin
• 03760243000959: HEMOSTASYL is a paste to be used as a haemostatic dressing with a mechanical action. Kit contain
• 03760243000942: box with 40 angled application cannulas for Hemostasyl paste in syringe
• 03760243000935: HEMOSTASYL is an original paste to be used as a haemostatic dressing with a mechanical action. B
• 03760243000010: Ribbon for stabilization of mobile teeth