FDA.reportPublic FDA data

E-Guide Soft

Primary DI
04260683220140
Brand
E-Guide Soft
Company
Envisiontec GmbH
Model
RES-01-3115
Catalog number
RES-01-3115
Device description
E-Guide Soft is a light-curing material for the additive manufacturing of nasopharyngeal and oropharyngeal swabs
Published
2020-10-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KXFApplicator, Absorbent Tipped, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXFApplicator, Absorbent Tipped, Non-SterileGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260683220140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260683220140042606832201404260683220140

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose absorbent tip applicator/swab, single-useA hand-held manual device, also known as a cotton bud or swab, in the form of a stick made of wood, paper, or plastic, with a single- or double-ended absorbent tip (e.g., cotton pledget), intended for cleaning or applying a substance (e.g., medication) to a superficial wound or body orifice, and to take specimens from a patient. It is not dedicated to a particular body area or orifice, and is used in a healthcare setting and in the home. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Protect from sunlight
Storage Environment Temperature41 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49204398750info@envisiontec.com

Regulatory Flags#

DUNS number
332025159
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260683220652SmileGuardRES-01-3194RES-01-31942022-08-19
04260683220041E-Guard BlueRES-01-3121RES-01-31212020-12-17
04260683220102E-GuardRES-01-3113RES-01-31132020-12-02
04260683220911Flexcera Base Ultra+ PinkRES-01-3500RES-01-35002023-09-13
04260683220928Flexcera™ Base Ultra+ Medium PinkRES-01-3501RES-01-35012023-09-13
04260683220935Flexcera™ Base Ultra+ Dark PinkRES-01-3502RES-01-35022023-09-13
04260683220942Flexcera Base Ultra+ Light PinkRES-01-3503RES-01-35032023-09-13
04260683220959Flexcera Base Ultra+ Dark MeharryRES-01-3504RES-01-35042023-09-13
04260683220836Flexcera™ Smile Ultra+ for Carbon® Printers BleachRES-01-3351RES-01-33512023-08-02
04260683220843Flexcera™ Smile Ultra+ for Carbon® Printers A1RES-01-3346RES-01-33462023-08-02
04260683220850Flexcera™ Smile Ultra+ for Carbon® Printers A2RES-01-3347RES-01-33472023-08-02
04260683220867Flexcera™ Smile Ultra+ for Carbon® Printers B1RES-01-3350RES-01-33502023-08-02
04260683220409Flexcera™ Smile Ultra+ A1RES-01-3146RES-01-31462022-01-21
04260683220416Flexcera™ Smile Ultra+ A2RES-01-3147RES-01-31472022-01-21
04260683220423Flexcera™ Smile Ultra+ A3RES-01-3148RES-01-31482022-01-21
04260683220430Flexcera™ Smile Ultra+ A3.5RES-01-3149RES-01-31492022-01-21
04260683220447Flexcera™ Smile Ultra+ B1RES-01-3150RES-01-31502022-01-21
04260683220454Flexcera™ Smile Ultra+ BleachRES-01-3151RES-01-31512022-01-21
04260683220461Flexcera™ Smile Ultra+ A1 0.5kgRES-01-3182RES-01-31822022-01-21
04260683220478Flexcera™ Smile Ultra+ A2 0.5kgRES-01-3183RES-01-31832022-01-21

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