Osstell SmartPeg Type 49 100480

GUDID 09010522000441

ISQ Measurement Peg

Osstell AB

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• Primary Device ID: 09010522000441
• NIH Device Record Key: 38d298ed-1ed1-41f1-91be-bd8775b578fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Osstell SmartPeg Type 49
• Version Model Number: Osstell SmartPeg Type 49
• Catalog Number: 100480
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	09010522000441 [Package]; Contains: 09010522001585; Package: Box [5 Units]; In Commercial Distribution
GS1	09010522001585 [Primary]

FDA Product Code

• EKX: Handpiece, Direct Drive, Ac-Powered

Sterilization

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

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

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