SPI®NEVO/ELEMENT PROFILE DRILL PF 4.0, extra short, L 29.0 mm, reusable

GUDID 07640182644116

Thommen Medical AG

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Primary Device ID07640182644116
NIH Device Record Keyc0d6c255-c338-49b4-b287-59c8eda0d6fb
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPI®NEVO/ELEMENT PROFILE DRILL PF 4.0, extra short, L 29.0 mm, reusable
Version Model Number3.03.752
Company DUNS481614829
Company NameThommen Medical AG
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107640182644116 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07640182644116]

Moist Heat or Steam Sterilization


[07640182644116]

Moist Heat or Steam Sterilization


[07640182644116]

Moist Heat or Steam Sterilization


[07640182644116]

Moist Heat or Steam Sterilization


[07640182644116]

Moist Heat or Steam Sterilization


[07640182644116]

Moist Heat or Steam Sterilization


[07640182644116]

Moist Heat or Steam Sterilization


[07640182644116]

Moist Heat or Steam Sterilization


[07640182644116]

Moist Heat or Steam Sterilization


[07640182644116]

Moist Heat or Steam Sterilization


[07640182644116]

Moist Heat or Steam Sterilization


[07640182644116]

Moist Heat or Steam Sterilization


[07640182644116]

Moist Heat or Steam Sterilization


[07640182644116]

Moist Heat or Steam Sterilization


[07640182644116]

Moist Heat or Steam Sterilization


[07640182644116]

Moist Heat or Steam Sterilization


[07640182644116]

Moist Heat or Steam Sterilization


[07640182644116]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-22
Device Publish Date2024-02-14

Devices Manufactured by Thommen Medical AG

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07640182643386 - SPI®NEVO RC INICELL®, healing cap incl., PF 3.5, endosseous Ø 3.5 mm, L 12.5 mm2024-02-22
07640182643393 - SPI®NEVO RC INICELL®, healing cap incl., PF 3.5, endosseous Ø 3.5 mm, L 14.0 mm2024-02-22
07640182643409 - SPI®NEVO RC INICELL®, healing cap incl., PF 4.0, endosseous Ø 4.0 mm, L 6.5 mm2024-02-22
07640182643416 - SPI®NEVO RC INICELL®, healing cap incl., PF 4.0, endosseous Ø 4.0 mm, L 8.0 mm2024-02-22
07640182643423 - SPI®NEVO RC INICELL®, healing cap incl., PF 4.0, endosseous Ø 4.0 mm, L 9.5 mm2024-02-22

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