Osstell IDx Instrument 101000

GUDID 09010522000847

ISQ Measurement Instrument

Osstell AB

Dental implant stability measurement control unit
Primary Device ID09010522000847
NIH Device Record Keybb2424c6-fee3-4a7d-821d-305a44058ced
Commercial Distribution StatusIn Commercial Distribution
Brand NameOsstell IDx Instrument
Version Model NumberOsstell Osstell IDx Instrument
Catalog Number101000
Company DUNS633171269
Company NameOsstell 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 Usefalse
Lot Batchfalse
Serial Numbertrue
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
GS109010522000847 [Package]
Contains: 09010522000892
Package: Box [1 Units]
In Commercial Distribution
GS109010522000854 [Package]
Contains: 09010522000892
Package: Box DEMO [1 Units]
In Commercial Distribution
GS109010522000892 [Primary]

FDA Product Code

EKXHandpiece, Direct Drive, Ac-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-06-04
Device Publish Date2022-11-01

Devices Manufactured by Osstell AB

09010522000847 - Osstell IDx Instrument2024-06-04ISQ Measurement Instrument
09010522000847 - Osstell IDx Instrument2024-06-04 ISQ Measurement Instrument
09010522001134 - DIO IDx Instrument2024-06-04 ISQ Measurement Instrument
09010522002476 - SmartPeg Type 1172024-05-23 ISQ Measurement Peg
09010522002070 - SmartPeg Type 98 - Neoss2024-05-22 ISQ Measurement Peg
09010522002469 - Neoss SmartPeg Mount2023-12-14 SmartPeg Mount
09010522002087 - Osstell SmartPeg Type 992023-11-09
09010522002117 - Osstell SmartPeg Type 1002023-11-09 ISQ Measurement Peg
09010522002131 - Osstell SmartPeg Type 1012023-11-09 ISQ Measurement Peg

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