FDA.reportPublic FDA data

Classic by RISKONTROL

Primary DI
03760243009921
Brand
Classic by RISKONTROL
Company
PRODUITS DENTAIRES PIERRE ROLLAN
Model
RISKONTROL
Catalog number
201665
Device description
Disposable single use tips for air/water syringe
Published
2022-09-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ECBUnit, Syringe, Air And/Or Water

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECBUnit, Syringe, Air And/Or WaterDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760243000508PrimaryGS10
03760243009921Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760243000508037602430005083760243000508
03760243009921037602430099213760243009921

GMDN Terms#

Term, Definition table
TermDefinition
Surgical mist irrigation tipA device that is designed to deliver a combined stream of air and mist to clear blood from a specific area of a surgical site. This device is a special perforated tip which can be affixed to an appropriate kind of tubing that delivers the rinsing fluids. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
277657631
Device count
250
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760243009907Classic by RISKONTROLRISKONTROL2016692025-04-01
03760243009853Art by RISKONTROLRISKONTROL2017002022-09-20
03760243009914Classic by RISKONTROLRISKONTROL2016642022-09-20
03760243009938Classic by RISKONTROLRISKONTROL2016662022-09-20
03760243009945Classic by RISKONTROLRISKONTROL2016672022-09-20
03760243009952Classic by RISKONTROLRISKONTROL2016682022-09-20
03760243009969Total protec by RISKONTROLRISKONTROL2017502022-09-20
03760243009808EXPASYL x20EXPASYL2610302022-09-20
03760243007040EXPASYL strawberry flavor EXPASYL2610012022-09-20
03760243009822Expasyl cannulasEXPASYL2610052022-09-20
03760243009839Expasyl cannulasEXPASYL2610152022-09-20
03760243007033EXPASYL x6EXPASYL2940102022-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810230800116DCI PartsDCI International, LLCECB2026-06-26
00810230800123DCI PartsDCI International, LLCECB2026-06-26
00810230800130DCI PartsDCI International, LLCECB2026-06-26
00810230800147DCI PartsDCI International, LLCECB2026-06-26
00810230800154DCI PartsDCI International, LLCECB2026-06-26
00810230800161DCI PartsDCI International, LLCECB2026-06-26
00810230800178DCI PartsDCI International, LLCECB2026-06-26
00810230800185DCI PartsDCI International, LLCECB2026-06-26
00810230800192DCI PartsDCI International, LLCECB2026-06-26
00810230800208DCI PartsDCI International, LLCECB2026-06-26
00810230800215DCI PartsDCI International, LLCECB2026-06-26
00810230800222DCI PartsDCI International, LLCECB2026-06-26
00810230800239DCI PartsDCI International, LLCECB2026-06-26
00810230800246DCI PartsDCI International, LLCECB2026-06-26
00810230800253DCI PartsDCI International, LLCECB2026-06-26
00810230800260DCI PartsDCI International, LLCECB2026-06-26
00810230800277DCI PartsDCI International, LLCECB2026-06-26
00810230800284DCI PartsDCI International, LLCECB2026-06-26
00810230800291DCI PartsDCI International, LLCECB2026-06-26
00810230800307DCI PartsDCI International, LLCECB2026-06-26
00810230800314DCI PartsDCI International, LLCECB2026-06-26
00810230800321DCI PartsDCI International, LLCECB2026-06-26
00810230800338DCI PartsDCI International, LLCECB2026-06-26
00810230800345DCI PartsDCI International, LLCECB2026-06-26
00810230800352DCI PartsDCI International, LLCECB2026-06-26
00810230800369DCI PartsDCI International, LLCECB2026-06-26
00810230800376DCI PartsDCI International, LLCECB2026-06-26
00810230800383DCI PartsDCI International, LLCECB2026-06-26
00810230800390DCI PartsDCI International, LLCECB2026-06-26
00810230800406DCI PartsDCI International, LLCECB2026-06-26