AccessGUDID - DEVICE: ACTEON (03760243000959)

GUDID

Device Identifier (DI) Information

Brand Name: ACTEON
Version or Model: Hemostasyl Kit
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 246200
Company Name: PRODUITS DENTAIRES PIERRE ROLLAN

Primary DI Number: 03760243000959
Issuing Agency: GS1
Commercial Distribution End Date: April 22, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 277657631 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47917	Non-organic haemostatic agent	A non-bioabsorbable device made of mineral and/or synthetic polymer components (e.g., smectite, potassium ferrate/hydrophilic polymer) intended for application to a bleeding external epithelial wound [i.e., skin wound or gastrointestinal (GI) mucosa wound] to facilitate local haemostasis through formation of a sealant and/or clot acceleration; it might additionally be intended to absorb bodily fluids. It is available in various forms (e.g., powder, gel, impregnated gauze) intended to be applied directly or endoscopically to the wound temporarily; it does not contain an antimicrobial agent. Disposable manual or electronic devices for application may be included. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MVL	Cord, Retraction

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K082116	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 5 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c4f10845-6278-49b2-b5e1-8976c5d89214
Public Version Date: April 23, 2025
Public Version Number: 3
DI Record Publish Date: March 04, 2020