PROTESIL INDURENT GEL 60 ML 056021

GUDID 68033712561150

Catalyst for C-silicones

VANNINI DENTAL INDUSTRY SRL

Silicone dental impression material
Primary Device ID68033712561150
NIH Device Record Key684fa3e0-407f-4552-973f-c84e55696d91
Commercial Distribution StatusIn Commercial Distribution
Brand NamePROTESIL INDURENT GEL 60 ML
Version Model Number056021
Catalog Number056021
Company DUNS436650394
Company NameVANNINI DENTAL INDUSTRY SRL
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+39055644698
Emailinfo@vanninidental.com
Phone+39055644698
Emailinfo@vanninidental.com
Phone+39055644698
Emailinfo@vanninidental.com
Phone+39055644698
Emailinfo@vanninidental.com
Phone+39055644698
Emailinfo@vanninidental.com
Phone+39055644698
Emailinfo@vanninidental.com
Phone+39055644698
Emailinfo@vanninidental.com
Phone+39055644698
Emailinfo@vanninidental.com
Phone+39055644698
Emailinfo@vanninidental.com
Phone+39055644698
Emailinfo@vanninidental.com
Phone+39055644698
Emailinfo@vanninidental.com
Phone+39055644698
Emailinfo@vanninidental.com
Phone+39055644698
Emailinfo@vanninidental.com
Phone+39055644698
Emailinfo@vanninidental.com
Phone+39055644698
Emailinfo@vanninidental.com
Phone+39055644698
Emailinfo@vanninidental.com
Phone+39055644698
Emailinfo@vanninidental.com

Device Dimensions

Total Volume60 Milliliter
Total Volume60 Milliliter
Total Volume60 Milliliter
Total Volume60 Milliliter
Total Volume60 Milliliter
Total Volume60 Milliliter
Total Volume60 Milliliter
Total Volume60 Milliliter
Total Volume60 Milliliter
Total Volume60 Milliliter
Total Volume60 Milliliter
Total Volume60 Milliliter
Total Volume60 Milliliter
Total Volume60 Milliliter
Total Volume60 Milliliter
Total Volume60 Milliliter
Total Volume60 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 4 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 4 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 4 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 4 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 4 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 4 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 4 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 4 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 4 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 4 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 4 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 4 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 4 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 4 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 4 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 4 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 4 Degrees Celsius and 28 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108033712561158 [Primary]
GS168033712561150 [Package]
Contains: 08033712561158
Package: BOX [72 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELWMATERIAL, IMPRESSION

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-09-16
Device Publish Date2019-09-06

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18033712560219 - CROMATIC 453g2019-09-16 Alginate for dental impressions
18033712560226 - KROMALGIN Piu 453g2019-09-16 Alginate for dental impressions
18033712560233 - CLIPALGIN 453g2019-09-16 Alginate for dental impressions
38033712560251 - CLIPALGIN 18 g2019-09-16 Alginate for dental impressions
38033712560268 - CROMATIC 18 g2019-09-16 Alginate for dental impressions
48033712560319 - PROTESIL ELASTIC RAPID 500g2019-09-16 Alginate for dental impressions
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