UNIVERSAL PLUS PLATFORM POSITIONER (2 UNITS)

GUDID 08435389825357

BIOTECHNOLOGY INSTITUTE SL

Dental implantation depth/angle gauge, reusable Dental implantation depth/angle gauge, reusable Dental implantation depth/angle gauge, reusable Dental implantation depth/angle gauge, reusable Dental implantation depth/angle gauge, reusable Dental implantation depth/angle gauge, reusable Dental implantation depth/angle gauge, reusable Dental implantation depth/angle gauge, reusable Dental implantation depth/angle gauge, reusable Dental implantation depth/angle gauge, reusable Dental implantation depth/angle gauge, reusable Dental implantation depth/angle gauge, reusable Dental implantation depth/angle gauge, reusable Dental implantation depth/angle gauge, reusable Dental implantation depth/angle gauge, reusable Dental implantation depth/angle gauge, reusable Dental implantation depth/angle gauge, reusable
Primary Device ID08435389825357
NIH Device Record Key963be1b3-fb94-4e59-99e7-6d722614d0a8
Commercial Distribution StatusIn Commercial Distribution
Brand NameUNIVERSAL PLUS PLATFORM POSITIONER (2 UNITS)
Version Model NumberCPUP
Company DUNS461665312
Company NameBIOTECHNOLOGY INSTITUTE SL
Device Count2
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108435389805311 [Primary]
GS108435389825357 [Unit of Use]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08435389825357]

Moist Heat or Steam Sterilization


[08435389825357]

Moist Heat or Steam Sterilization


[08435389825357]

Moist Heat or Steam Sterilization


[08435389825357]

Moist Heat or Steam Sterilization


[08435389825357]

Moist Heat or Steam Sterilization


[08435389825357]

Moist Heat or Steam Sterilization


[08435389825357]

Moist Heat or Steam Sterilization


[08435389825357]

Moist Heat or Steam Sterilization


[08435389825357]

Moist Heat or Steam Sterilization


[08435389825357]

Moist Heat or Steam Sterilization


[08435389825357]

Moist Heat or Steam Sterilization


[08435389825357]

Moist Heat or Steam Sterilization


[08435389825357]

Moist Heat or Steam Sterilization


[08435389825357]

Moist Heat or Steam Sterilization


[08435389825357]

Moist Heat or Steam Sterilization


[08435389825357]

Moist Heat or Steam Sterilization


[08435389825357]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-07
Device Publish Date2023-06-29

Devices Manufactured by BIOTECHNOLOGY INSTITUTE SL

08435389825340 - SHORT POSITIONER FOR UNIVERSAL PLATFORM (2 UNITS)2024-05-29
08435389812081 - INTERNA® UNIVERSAL PLATFORM IMPLANT CA D:3,5 L:6,52024-05-29
08435389812173 - INTERNA® UNIVERSAL PLATFORM IMPLANT CA D:3,75 L:6,52024-05-29
08435389812258 - INTERNA® UNIVERSAL PLATFORM IMPLANT CA D:4 L:5,52024-05-29
08435389812333 - INTERNA® UNIVERSAL PLATFORM IMPLANT CA D:4,25 L:5,52024-05-29
08435389812692 - CASE FOR IMPLANT EXTRACTION KIT2024-05-29
08435389822912 - PLATFORM CENTRING DEVICES FOR SURGERY2024-05-29
08435389825135 - LONG TREPHINE DRILL; INTERNAL Ø 4,3 MM; L: 8 MM 2024-05-29

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