Penguin II 55241

GUDID 07350096320340

Integration Diagnostics Sweden AB

Multimeter Multimeter Multimeter Multimeter Multimeter Multimeter Multimeter Multimeter Multimeter Multimeter Multimeter Multimeter Multimeter Multimeter Multimeter Multimeter Multimeter

• Primary Device ID: 07350096320340
• NIH Device Record Key: 81f380c3-df6a-417e-98de-2801deab8ed2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Penguin II
• Version Model Number: Penguin II Instrument
• Catalog Number: 55241
• 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	07350096320333 [Primary]
GS1	07350096320340 [Package]; Contains: 07350096320333; Package: PenguinIISet Klockne [1 Units]; In Commercial Distribution
GS1	07350096320371 [Package]; Contains: 07350096320333; Package: Penguin II Demo Set [1 Units]; In Commercial Distribution
GS1	07350096320456 [Package]; Contains: 07350096320333; Package: IS4 Instrument Set [1 Units]; In Commercial Distribution
GS1	07350096320463 [Package]; Contains: 07350096320333; Package: PenguinIISet Citagen [1 Units]; In Commercial Distribution
GS1	07350096320470 [Package]; Contains: 07350096320333; Package: PenguinIISet Bredent [1 Units]; In Commercial Distribution

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: 2023-12-28
• Device Publish Date: 2023-12-20

Devices Manufactured by Integration Diagnostics Sweden AB

• 07350096320425 - Penguin MDI: 2023-12-29
• 07350096320432 - MulTipeg™: 2023-12-29
• 07350096320449 - Penguin MDI: 2023-12-29
• 07350096320340 - Penguin II: 2023-12-28
• 07350096320340 - Penguin II: 2023-12-28
• 07350096320043 - Penguin RFA: 2022-03-16
• 07350096320050 - Penguin RFA: 2022-03-16
• 07350096320067 - Penguin RFA: 2022-03-16
• 07350096320197 - Penguin RFA: 2022-03-16