Prosthetic Silicone Materials S25(500g)

GUDID 05060483012155

Silicone materials for manufacture of adhesive or implant retained external maxillofacial materials

TECHNOVENT LIMITED

Dental appliance fabrication material, resin
Primary Device ID05060483012155
NIH Device Record Keyb3ea6dd6-773a-4972-90fc-ba996d48fae4
Commercial Distribution StatusIn Commercial Distribution
Brand NameProsthetic Silicone Materials
Version Model NumberTechSil 25 – 500g
Catalog NumberS25(500g)
Company DUNS225835156
Company NameTECHNOVENT LIMITED
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.

Device Identifiers

Device Issuing AgencyDevice ID
GS105060483012155 [Primary]

FDA Product Code

GBIMaterial, External Aesthetic Restoration, Used With Adhesive

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-30
Device Publish Date2024-07-22

On-Brand Devices [Prosthetic Silicone Materials]

05060483016283Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
05060483016276Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
05060483016269Silicone polymer-based additives designed to thicken uncured prosthetic silicones.
05060483016252Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
05060483016245Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
05060483016238Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
05060483016221Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
05060483016214Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
05060483016207Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
05060483016191Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
05060483016184Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
05060483016177Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
05060483016108Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
05060483013138Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
05060483013114Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
05060483013107Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
05060483013084Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
05060483013077Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
05060483013053Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
05060483013046Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
05060483013022Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
05060483013015Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
05060483012995Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
05060483012704Technovent Extrinsic Colours and Sealant are products to extrinsically colour and seal colours o
05060483012698Technovent Extrinsic Colours and Sealant are products to extrinsically colour and seal colours o
05060483012476Cartridge based silicone materials for taking external impressions to aid the construction of pr
05060483012452Cartridge based silicone materials for taking external impressions to aid the construction of pr
05060483012162Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
05060483012155Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
05060483012148Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
05060483012131Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
05060483012124Silicone polymer-based additives designed to thicken uncured prosthetic silicones.
05060483012117Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
05060483012100Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
05060483012094Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
05060483012087Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi

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