SmartPeg Type 98 - Neoss 91073

GUDID 09010522002070

ISQ Measurement Peg

Osstell AB

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• Primary Device ID: 09010522002070
• NIH Device Record Key: 2f9f1851-1099-4bad-a02e-270592750b67
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartPeg Type 98 - Neoss
• Version Model Number: SmartPeg Type 98 - Neoss
• Catalog Number: 91073
• 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: true
• 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	09010522002070 [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: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-22
• Device Publish Date: 2024-05-14

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• 09010522002070 - SmartPeg Type 98 - Neoss: 2024-05-22ISQ Measurement Peg
• 09010522002070 - SmartPeg Type 98 - Neoss: 2024-05-22 ISQ Measurement Peg
• 09010522002469 - Neoss SmartPeg Mount: 2023-12-14 SmartPeg Mount
• 09010522002087 - Osstell SmartPeg Type 99: 2023-11-09
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