Select Sil Light Body SEL-SIL-LB-SHFS-50

GUDID 17540208000445

Super hydrophilic correction impression material based on addition curing vinyl silicones - Light body, fast set

Zendo Direct AG

Silicone dental impression material
Primary Device ID17540208000445
NIH Device Record Keydfa0ee98-1465-419d-ab25-d2c7a3a816c9
Commercial Distribution StatusIn Commercial Distribution
Brand NameSelect Sil Light Body
Version Model NumberSEL-SIL-LB-SHFS-50
Catalog NumberSEL-SIL-LB-SHFS-50
Company DUNS486717338
Company NameZendo Direct AG
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 Usefalse
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

Special Storage Condition, SpecifyBetween 0 and 0 *Storage temperature: max. 77°F (25°C)

Device Identifiers

Device Issuing AgencyDevice ID
GS107540208000448 [Primary]
GS117540208000445 [Package]
Contains: 07540208000448
Package: Carton [2 Units]
In Commercial Distribution

FDA Product Code

ELWMaterial, Impression

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-03-07

On-Brand Devices [Select Sil Light Body]

17540208000445Super hydrophilic correction impression material based on addition curing vinyl silicones - Ligh
17540208000216Super hydrophilic correction impression material based on addition curing vinyl silicones - Ligh

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