Anew Implant System

GUDID 07350081495138

Dentatus Anew Implant

Dentatus AB

Transgingival implant
Primary Device ID07350081495138
NIH Device Record Key1dc6ec0c-241c-4ea2-8987-f00ff3108fd8
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnew Implant System
Version Model NumberST-24S
Company DUNS355803412
Company NameDentatus AB
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+46854650900
Emailinfo@dentatus.se

Device Identifiers

Device Issuing AgencyDevice ID
GS107350081494773 [Package]
Package: Implant pack [2 Units]
In Commercial Distribution
GS107350081494780 [Package]
Package: Implant pack [1 Units]
In Commercial Distribution
GS107350081495138 [Primary]

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2015-08-20

On-Brand Devices [Anew Implant System]

07350081495138Dentatus Anew Implant
07350081495121Dentatus Anew Implant, blister pack including 1 pc
07350081495114Dentatus Anew Implant, blister pack including 1 pc
07350081495107Dentatus Anew Implant, blister pack including 1 pc
07350081495091Dentatus Anew Implant, blister pack including 1 pc
07350081495084Dentatus Anew Implant, blisterpack including 1 pc
07350081495077Dentatus Anew Implant, blister pack including 1 pc
07350081495060Dentatus Anew Implant, blister pack including 1 pc
07350081495053Dentatus Anew Implant, blister pack including 1 pc
07350081495343Dentatus Anew Implant, blister pack including 1 pc

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