PROBE 418 Master Probe

GUDID 07332834000509

PROBE 418 Master Probe

Perimed AB

Laser Doppler blood flowmeter Laser Doppler blood flowmeter Laser Doppler blood flowmeter Laser Doppler blood flowmeter Laser Doppler blood flowmeter Laser Doppler blood flowmeter Laser Doppler blood flowmeter Laser Doppler blood flowmeter Laser Doppler blood flowmeter Laser Doppler blood flowmeter Laser Doppler blood flowmeter Laser Doppler blood flowmeter Laser Doppler blood flowmeter Laser Doppler blood flowmeter Laser Doppler blood flowmeter Laser Doppler blood flowmeter Laser Doppler blood flowmeter

• Primary Device ID: 07332834000509
• NIH Device Record Key: 1f171efc-72c2-4aab-94e9-004efae43ef1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROBE 418 Master Probe
• Version Model Number: PROBE 418
• Company DUNS: 354765570
• Company Name: Perimed AB
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07332834000509 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K935495

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-13

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