Penguin MDI 55280

GUDID 07350096320425

Integration Diagnostics Sweden AB

Multimeter

• Primary Device ID: 07350096320425
• NIH Device Record Key: e63a70cf-90d0-4121-911b-e6e1a19bbe00
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Penguin MDI
• Version Model Number: Penguin MDI Instrument
• Catalog Number: 55280
• Company DUNS: 352736781
• Company Name: Integration Diagnostics Sweden AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	07350096320418 [Primary]
GS1	07350096320425 [Package]; Contains: 07350096320418; Package: PenguinMDI Instr Kit [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143445

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: 2023-12-29
• Device Publish Date: 2023-12-21

On-Brand Devices [Penguin MDI]

• 07350096320449: Penguin MDI Locking Screwdriver
• 07350096320425: Penguin MDI Instrument