E-Guide Soft RES-01-3115

GUDID 04260683220140

E-Guide Soft is a light-curing material for the additive manufacturing of nasopharyngeal and oropharyngeal swabs

Envisiontec GmbH

General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use
Primary Device ID04260683220140
NIH Device Record Key95eeae54-5d1f-4001-9948-51ab17f13d71
Commercial Distribution Discontinuation2020-10-08
Commercial Distribution StatusNot in Commercial Distribution
Brand NameE-Guide Soft
Version Model NumberRES-01-3115
Catalog NumberRES-01-3115
Company DUNS332025159
Company NameEnvisiontec GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com
Phone+49204398750
Emailinfo@envisiontec.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS104260683220140 [Primary]

FDA Product Code

KXFApplicator, Absorbent Tipped, Non-Sterile

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-15
Device Publish Date2020-10-07

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04260683220942 - Flexcera Base Ultra+ Light Pink2023-09-21 Flexcera Base Ultra+ is a light-curing material for the additive manufacturing of individual and removable full and partial dent
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