Osstell IDx Instrument 101000

GUDID 09010522000847

ISQ Measurement Instrument

Osstell AB

Dental implant stability measurement control unit

• Primary Device ID: 09010522000847
• NIH Device Record Key: bb2424c6-fee3-4a7d-821d-305a44058ced
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Osstell IDx Instrument
• Version Model Number: Osstell Osstell IDx Instrument
• Catalog Number: 101000
• 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	09010522000847 [Package]; Contains: 09010522000892; Package: Box [1 Units]; In Commercial Distribution
GS1	09010522000854 [Package]; Contains: 09010522000892; Package: Box DEMO [1 Units]; In Commercial Distribution
GS1	09010522000892 [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

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• 09010522002568 - Osstell SmartPeg Type 113: 2025-04-04 ISQ Measurement Peg
• 09010522002582 - Osstell SmartPeg Type 114: 2025-04-04 ISQ Measurement Peg
• 09010522002605 - Osstell SmartPeg Type 115: 2025-04-04 ISQ Measurement Peg
• 09010522002636 - Osstell Classic Instrument: 2025-03-31 ISQ Measurement Instrument
• 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