Odyssey Micro Catheter

GUDID 00857834006933

HERAEUS MEDICAL COMPONENTS, LLC

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• Primary Device ID: 00857834006933
• NIH Device Record Key: 8898398e-5a3b-431d-83b1-8b5975c1966f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Odyssey Micro Catheter
• Version Model Number: OMC003
• Company DUNS: 080645456
• Company Name: HERAEUS MEDICAL COMPONENTS, LLC
• 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: false
• 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	00857834006933 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170664

FDA Product Code

• DQY: Catheter, Percutaneous

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-04-09
• Device Publish Date: 2017-11-13

On-Brand Devices [Odyssey Micro Catheter]

• 00857834006933: OMC003
• 00857834006605: OMC-007