ACTEON

Basic Information

• Brand Name: ACTEON
• Primary DI: 03760243000935
• Version / Model: Hemostasyl syringes
• Catalog Number: 246050
• Company Name: PRODUITS DENTAIRES PIERRE ROLLAN
• Labeler DUNS: 277657631
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-04
• Public Version: 1
• Public Version Date: 2020-03-12
• Public Version Status: New
• Public Device Record Key: 55f1bf63-eccd-4c5b-89eb-84edcf5bf970

Device Description

HEMOSTASYL is an original paste to be used as a haemostatic dressing with a mechanical action. Box with 2 x 2g multiple use syringes of HEMOSTASYL paste

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MVL	Cord, Retraction	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
61905	Inorganic haemostatic agent, non-sterile	A non-sterile, non-bioabsorbable device made of mineral and/or synthetic polymer components (e.g., aluminium chloride) intended for application to a bleeding external epithelial wound [i.e., skin wound or gastrointestinal (GI) mucosa wound] to facilitate local haemostasis by creating a physical barrier to bleeding and/or clot acceleration; it may also be intended to absorb bodily fluids and does not contain an antimicrobial agent. It is available in various forms (e.g., solution, powder, gel) and can be applied directly or endoscopically to the wound where it forms a seal until physically removed; various disposable applicators may be included. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03760243000935	GS1
Package	03760243007125	GS1		2	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K082116	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 25 Degrees Celsius