DIO IDx Instrument 100501

GUDID 09010522001134

ISQ Measurement Instrument

Osstell AB

Dental implant stability measurement control unit

• Primary Device ID: 09010522001134
• NIH Device Record Key: 1b81a53e-65dc-4c20-b2e7-d13326f66d5a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIO IDx Instrument
• Version Model Number: Osstell DIO IDx Instrument
• Catalog Number: 100501
• Company DUNS: 633171269
• Company Name: Osstell AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09010522001134 [Package]; Contains: 09010522001141; Package: Box [1 Units]; In Commercial Distribution
GS1	09010522001141 [Primary]

FDA Product Code

• EKX: Handpiece, Direct Drive, Ac-Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-06-04
• Device Publish Date: 2022-11-01

Devices Manufactured by Osstell AB

• 09010522000731 - Osstell ISQ Probe: 2024-09-19 ISQ Measurement Instrument Accessory
• 09010522002315 - Osstell SmartPeg Type 110: 2024-09-19 ISQ Measurement Peg
• 09010522002322 - Osstell SmartPeg Type 111: 2024-09-19 ISQ Measurement Peg
• 09010522000847 - Osstell IDx Instrument: 2024-06-04 ISQ Measurement Instrument
• 09010522001134 - DIO IDx Instrument: 2024-06-04ISQ Measurement Instrument
• 09010522001134 - DIO IDx Instrument: 2024-06-04 ISQ Measurement Instrument
• 09010522002476 - SmartPeg Type 117: 2024-05-23 ISQ Measurement Peg
• 09010522002070 - SmartPeg Type 98 - Neoss: 2024-05-22 ISQ Measurement Peg
• 09010522002469 - Neoss SmartPeg Mount: 2023-12-14 SmartPeg Mount