FDA.reportPublic FDA data

ACTEON

Primary DI
03760243000935
Brand
ACTEON
Company
ACTEON MANUFACTURING
Model
Hemostasyl syringes
Catalog number
246050
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
Published
2020-03-04
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MVLCord, Retraction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVLCord, RetractionUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082116000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082116000HEMOSTASYL PASTESatelec2008-12-17MVL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760243007125PackageGS12In Commercial Distribution
03760243000935PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760243007125037602430071253760243007125
03760243000935037602430009353760243000935

GMDN Terms#

Term, Definition table
TermDefinition
Inorganic haemostatic agent, non-sterileA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+33556340607info@acteongroup.com
+33(0)556349292acteon-manufacturing@acteongroup.com

Regulatory Flags#

DUNS number
283473691
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760243000430Art by RISKONTROLRISKONTROL2017002022-09-20
03760243000492Classic by RISKONTROLRISKONTROL2016642022-09-20
03760243000508Classic by RISKONTROLRISKONTROL2016652022-09-20
03760243000515Classic by RISKONTROLRISKONTROL2016662022-09-20
03760243000522Classic by RISKONTROLRISKONTROL2016672022-09-20
03760243000539Classic by RISKONTROLRISKONTROL2016682022-09-20
03760243000546Total protec by RISKONTROLRISKONTROL2017502022-09-20
03760243000706EXPASYL x20EXPASYL2610302022-09-20
03760243000713EXPASYL strawberry flavor EXPASYL2610012022-09-20
03760243000720Expasyl cannulasEXPASYL2610402022-09-20
03760243000737Expasyl cannulasEXPASYL2610052022-09-20
03760243000744Expasyl cannulasEXPASYL2610452022-09-20
03760243000751Expasyl cannulasEXPASYL2610152022-09-20
03760243001093Classic by RISKONTROLRISKONTROL2016692025-04-01
03760243005008EXPASYL x6EXPASYL2940102022-09-20
03760243000027ADAPTATER RISKONTROL ADEC INOXRISKONTROL2001952024-03-21
03760243000089ADAPTATER RISKONTROL DCIRISKONTROL2001522024-03-21
03760243000263ADAPTATER RISKONTROL LU INOXRISKONTROL2001502024-03-21
03760243000270ADAPTATER RISKONTROL LU NEW INOXRISKONTROL2001992024-03-21
03760243000553Total protec by RISKONTROLRISKONTROL2017512022-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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J014661012760Retraxil blueKulzer GmbHMVL2026-04-21
J014661012770Retraxil blueKulzer GmbHMVL2026-04-21
J014661012780Retraxil blueKulzer GmbHMVL2026-04-21
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00008579280274sure EndoHexa DentalMVL2026-01-22
00850079280182Sure EndoHexa DentalMVL2026-01-22
00850079280199Sure EndoHexa DentalMVL2026-01-22
00850079280205Sure endoHexa DentalMVL2026-01-22
00850079280212Sure EndoHexa DentalMVL2026-01-22
00850079280229Sure endoHexa DentalMVL2026-01-22
00850079280236Sure EndoHexa DentalMVL2026-01-22
00850079280243Sure EndoHexa DentalMVL2026-01-22
00850079280250Sure EndoHexa DentalMVL2026-01-22
00850079280267Sure EndoHexa DentalMVL2026-01-22
00850079280281SDure endoHexa DentalMVL2026-01-22
00850079280175Sure EndoHexa DentalMVL2026-01-21
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10818207024975Traxodent Gel AlCl - Sample PackVista DentalMVL2025-06-30
10818207024982Traxodent Gel AlCl - Value PackVista DentalMVL2025-06-30
10818207024999Traxodent Gel AlCl - Refill KitVista DentalMVL2025-06-30
10818207025002Traxodent Gel FS - Bulk Syringe KitVista DentalMVL2025-06-30
10818207025019Traxodent Gel FS - Value PackVista DentalMVL2025-06-30
10818207025026Traxodent Gel FS - Refill KitVista DentalMVL2025-06-30
00359883005665Tissue Goo™ Hemostatic Gel 4-PackDEN-MAT HOLDINGS, LLCMVL2025-03-18
00359883005672Tissue Goo™ Hemostatic Gel Big Shot Syringe KitDEN-MAT HOLDINGS, LLCMVL2025-03-18
00359883005634First String Advanced Braided Retraction Cord Non-Impregnated - SmallDEN-MAT HOLDINGS, LLCMVL2025-03-12
00359883005641First String Advanced Braided Retraction Cord Non-Impregnated - MediumDEN-MAT HOLDINGS, LLCMVL2025-03-12
00359883005658First String Advanced Braided Retraction Cord Non-Impregnated - LargeDEN-MAT HOLDINGS, LLCMVL2025-03-12