ACTEON

GUDID 03760243001048

Expasyl is a paste for temporary gingival retraction that ensures separation of the marginal gingiva and drying of the sulcus

PRODUITS DENTAIRES PIERRE ROLLAN

Gingival retraction kit

• Primary Device ID: 03760243001048
• NIH Device Record Key: 8f8f0617-8b14-4554-9b74-36d055756dce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACTEON
• Version Model Number: EXPASYL EXACT
• 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: false
• 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: +33556340607
• Email: info@acteongroup.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760243001048 [Primary]
GS1	03760243007170 [Package]; Package: [20 Units]; In Commercial Distribution
GS1	03760243007187 [Package]; Package: [50 Units]; In Commercial Distribution
GS1	03760243007194 [Package]; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050180

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