SmartPeg Type 52 - Neoss 91072

GUDID 09010522002407

ISQ Measurement Peg

Osstell AB

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• Primary Device ID: 09010522002407
• NIH Device Record Key: 684b50af-a8ed-4297-9fca-5073c1abe0cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartPeg Type 52 - Neoss
• Version Model Number: SmartPeg Type 52 - Neoss
• Catalog Number: 91072
• 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	09010522002407 [Package]; Contains: 09010522002438; Package: Box [5 Units]; In Commercial Distribution
GS1	09010522002438 [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: 2023-11-09
• Device Publish Date: 2023-11-01

Devices Manufactured by Osstell AB

• 09010522002469 - Neoss SmartPeg Mount: 2023-12-14 SmartPeg Mount
• 09010522002087 - Osstell SmartPeg Type 99: 2023-11-09
• 09010522002117 - Osstell SmartPeg Type 100: 2023-11-09 ISQ Measurement Peg
• 09010522002131 - Osstell SmartPeg Type 101: 2023-11-09 ISQ Measurement Peg
• 09010522002155 - Osstell SmartPeg Type 102: 2023-11-09 ISQ Measurement Peg
• 09010522002162 - Osstell SmartPeg Type 103: 2023-11-09 ISQ Measurement Peg
• 09010522002186 - Osstell SmartPeg Type 104: 2023-11-09 ISQ Measurement Peg
• 09010522002223 - Osstell SmartPeg Type 106: 2023-11-09 ISQ Measurement Peg