Penguin MDI 55283

GUDID 07350096320449

Integration Diagnostics Sweden AB

Multimeter

• Primary Device ID: 07350096320449
• NIH Device Record Key: 41c0b64c-90d3-406b-bfa3-38c9379ce9c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Penguin MDI
• Version Model Number: Penguin MDI Locking Screwdriver
• Catalog Number: 55283
• Company DUNS: 352736781
• Company Name: Integration Diagnostics Sweden AB
• Device Count: 1
• DM Exempt: true
• 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: true
• Serial Number: false
• 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	07350096320449 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143445

FDA Product Code

• EKX: Handpiece, Direct Drive, Ac-Powered

Sterilization

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

[07350096320449]

Moist Heat or Steam Sterilization

[07350096320449]

Moist Heat or Steam Sterilization

[07350096320449]

Moist Heat or Steam Sterilization

[07350096320449]

Moist Heat or Steam Sterilization

[07350096320449]

Moist Heat or Steam Sterilization

[07350096320449]

Moist Heat or Steam Sterilization

[07350096320449]

Moist Heat or Steam Sterilization

[07350096320449]

Moist Heat or Steam Sterilization

[07350096320449]

Moist Heat or Steam Sterilization

[07350096320449]

Moist Heat or Steam Sterilization

[07350096320449]

Moist Heat or Steam Sterilization

[07350096320449]

Moist Heat or Steam Sterilization

[07350096320449]

Moist Heat or Steam Sterilization

[07350096320449]

Moist Heat or Steam Sterilization

[07350096320449]

Moist Heat or Steam Sterilization

[07350096320449]

Moist Heat or Steam Sterilization

[07350096320449]

Moist Heat or Steam Sterilization

[07350096320449]

Moist Heat or Steam Sterilization

[07350096320449]

Moist Heat or Steam Sterilization

[07350096320449]

Moist Heat or Steam Sterilization

[07350096320449]

Moist Heat or Steam Sterilization

[07350096320449]

Moist Heat or Steam Sterilization

[07350096320449]

Moist Heat or Steam Sterilization

[07350096320449]

Moist Heat or Steam Sterilization

[07350096320449]

Moist Heat or Steam Sterilization

[07350096320449]

Moist Heat or Steam Sterilization

[07350096320449]

Moist Heat or Steam Sterilization

[07350096320449]

Moist Heat or Steam Sterilization

[07350096320449]

Moist Heat or Steam Sterilization

[07350096320449]

Moist Heat or Steam Sterilization

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