Visalys Flow 15030

GUDID E217150301

Visalys Flow A1, 1 x 1,8 g Syringe (US)

Kettenbach GmbH & Co. KG

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Primary Device IDE217150301
NIH Device Record Keydf22a183-613d-4391-9b3e-4d1bf9892f72
Commercial Distribution StatusIn Commercial Distribution
Brand NameVisalys Flow
Version Model Number15030
Catalog Number15030
Company DUNS316803246
Company NameKettenbach GmbH & Co. KG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 73 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE217150301 [Primary]

FDA Product Code

EBCSealant, Pit And Fissure, And Conditioner

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-02
Device Publish Date2023-02-22

On-Brand Devices [Visalys Flow]

E217150361Visalys Flow Bleach, 1 x 1,8 g Syringe (US)
E217150351Visalys Flow Opaque A2, 1 x 1,8 g Syringe (US)
E217150341Visalys Flow A4, 1 x 1,8 g Syringe (US)
E217150331Visalys Flow A3.5, 1 x 1,8 g Syringe (US)
E217150321Visalys Flow A3, 1 x 1,8 g Syringe (US)
E217150311Visalys Flow A2, 1 x 1,8 g Syringe (US)
E217150301Visalys Flow A1, 1 x 1,8 g Syringe (US)

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