Osseo 100 Y1004175

GUDID 07350096320265

Integration Diagnostics Sweden AB

Multimeter

• Primary Device ID: 07350096320265
• NIH Device Record Key: 4addbb1d-943d-4c90-91cc-150d0421ae1a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Osseo 100
• Version Model Number: Osseo 100 Set
• Catalog Number: Y1004175
• 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	07350096320234 [Primary]
GS1	07350096320265 [Direct Marking]

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: 2022-03-09
• Device Publish Date: 2022-03-01

Devices Manufactured by Integration Diagnostics Sweden AB

• 07350096320272 - Osseo 100+: 2024-11-07
• 07350096320425 - Penguin MDI: 2023-12-29
• 07350096320432 - MulTipeg™: 2023-12-29
• 07350096320449 - Penguin MDI: 2023-12-29
• 07350096320340 - Penguin II: 2023-12-28
• 07350096320043 - Penguin RFA: 2022-03-16
• 07350096320050 - Penguin RFA: 2022-03-16
• 07350096320067 - Penguin RFA: 2022-03-16