Osstell Beacon Instrument 100668

GUDID 09010522000861

ISQ Measurement Instrument

Osstell AB

Dental implant stability measurement control unit

• Primary Device ID: 09010522000861
• NIH Device Record Key: 6aae81c1-8d7c-4217-aa86-821ff75c6b8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Osstell Beacon Instrument
• Version Model Number: Osstell Osstell Beacon Instrument
• Catalog Number: 100668
• Company DUNS: 633171269
• Company Name: Osstell AB
• Device Count: 1
• DM Exempt: true
• 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	09010522000861 [Package]; Contains: 09010522000885; Package: Box [1 Units]; In Commercial Distribution
GS1	09010522000878 [Package]; Package: Box DEMO [1 Units]; In Commercial Distribution
GS1	09010522000885 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181888

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-12
• Device Publish Date: 2022-09-02

On-Brand Devices [Osstell Beacon Instrument]

• 09010522000861: ISQ Measurement Instrument
• 09010522002650: ISQ Measurement Instrument