Osstell ISQ Probe 100501

GUDID 09010522000731

ISQ Measurement Instrument Accessory

Osstell AB

Dental implant stability resonance frequency analysis unit
Primary Device ID09010522000731
NIH Device Record Keye6599946-3bcc-4e6a-b9ce-12f3211118c4
Commercial Distribution StatusIn Commercial Distribution
Brand NameOsstell ISQ Probe
Version Model NumberOsstell ISQ Probe
Catalog Number100501
Company DUNS633171269
Company NameOsstell AB
Device Count1
DM Exempttrue
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 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
GS109010522000731 [Primary]

FDA Product Code

EKXHandpiece, Direct Drive, Ac-Powered

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09010522000731]

Moist Heat or Steam Sterilization


[09010522000731]

Moist Heat or Steam Sterilization


[09010522000731]

Moist Heat or Steam Sterilization


[09010522000731]

Moist Heat or Steam Sterilization


[09010522000731]

Moist Heat or Steam Sterilization


[09010522000731]

Moist Heat or Steam Sterilization


[09010522000731]

Moist Heat or Steam Sterilization


[09010522000731]

Moist Heat or Steam Sterilization


[09010522000731]

Moist Heat or Steam Sterilization


[09010522000731]

Moist Heat or Steam Sterilization


[09010522000731]

Moist Heat or Steam Sterilization


[09010522000731]

Moist Heat or Steam Sterilization


[09010522000731]

Moist Heat or Steam Sterilization


[09010522000731]

Moist Heat or Steam Sterilization


[09010522000731]

Moist Heat or Steam Sterilization


[09010522000731]

Moist Heat or Steam Sterilization


[09010522000731]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-09-19
Device Publish Date2022-11-01

Devices Manufactured by Osstell AB

09010522000731 - Osstell ISQ Probe2024-09-19ISQ Measurement Instrument Accessory
09010522000731 - Osstell ISQ Probe2024-09-19 ISQ Measurement Instrument Accessory
09010522002315 - Osstell SmartPeg Type 1102024-09-19 ISQ Measurement Peg
09010522002322 - Osstell SmartPeg Type 1112024-09-19 ISQ Measurement Peg
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

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