FDA.reportPublic FDA data

Acuflow

Primary DI
00858475006146
Brand
Acuflow
Company
DENTERPRISE INTERNATIONAL, INC.
Model
Acuflow
Device description
The Acuflow Anesthetic Delivery System is a device used for injection of local anesthetics for anesthesia administered prior to, or in conjunction with, dental procedure.
Published
2018-03-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858475006146PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858475006146008584750061468584750061460858475006146

GMDN Terms#

Term, Definition table
TermDefinition
Dental anaesthesia syringe cartridgeA plastic or glass container prefilled with a single dose of anaesthetic medication intended to be inserted into a dental anaesthesia syringe and injected into oral tissues for a dental procedure. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-5 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-509-3180info@denterpriseintl.com

Regulatory Flags#

DUNS number
024913248
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858475006337Smil-O-Ray12024-01-05
00858475006269QuickRay DX Size 1102QDX203002023-07-25
00858475006276QuickRay DX Size 2202QDX204002023-07-25
00858475006115iCam100001MAG100002022-02-03
00858475006177InstaRaySize 102HAM151022019-07-24
00858475006184InstaRaySize 202HAM153022019-07-24
00858475006016QuickRay HD #2Hama Size #22017-02-01
00858475006023QuickRay HD #1Hama Size #12017-02-01
00858475006030Uni-Ray HDHDI-S 1.52017-02-17
00858475006047 Quick Ray HD No Logo #1S11684-12 Hama Size #12017-02-01
00858475006054 QUICK Ray HD No Logo #2S11685-12 Hama Size #22017-02-01
00858475006009Xray2GoXray2Go 3mA2017-02-01
00858475006078QuickRay #1e2V Size #12017-02-01
00858475006085QuickRay #2e2V Size #22017-01-31
00858475006092Xray2Go MiniMiniX-V2017-02-01
00858475006153MOBILE-XT1002018-05-29
00858475006139EZ-FlowEZ-Flow2018-03-19