Visalys Fill 15005

GUDID E217150051

Visalys Fill A3.5, 1 x 4 g Syringe (US)

Kettenbach GmbH & Co. KG

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Primary Device IDE217150051
NIH Device Record Key3fa0f912-0fcf-402d-9bee-0df74a0112e1
Commercial Distribution StatusIn Commercial Distribution
Brand NameVisalys Fill
Version Model Number15005
Catalog Number15005
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
HIBCCE217150051 [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 Fill]

E217150181Visalys Fill Bleach, 15 x 0,25 g Caps (US)
E217150171Visalys Fill Opaque A2, 15 x 0,25 g Caps (US)
E217150161Visalys Fill A4, 15 x 0,25 g Caps (US)
E217150151Visalys Fill A3.5, 15 x 0,25 g Caps (US)
E217150141Visalys Fill A3, 15 x 0,25 g Caps (US)
E217150131Visalys Fill A2, 15 x 0,25 g Caps (US)
E217150121Visalys Fill A1, 15 x 0,25 g Caps (US)
E217150081Visalys Fill Bleach, 1 x 4 g Syringe (US)
E217150071Visalys Fill Opaque A2, 1 x 4 g Syringe (US)
E217150061Visalys Fill A4, 1 x 4 g Syringe (US)
E217150051Visalys Fill A3.5, 1 x 4 g Syringe (US)
E217150041Visalys Fill A3, 1 x 4 g Syringe (US)
E217150031Visalys Fill A2, 1 x 4 g Syringe (US)
E217150021Visalys Fill A1, 1 x 4 g Syringe (US)

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