UNITY TETRASPOT 8065000236

GUDID 10380650002362

25GA TETRASPOT MultiSpot Laser Probe

Alcon Laboratories, Inc.

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• Primary Device ID: 10380650002362
• NIH Device Record Key: 8e3ea273-e353-4e96-9f72-8b9135a61423
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNITY TETRASPOT
• Version Model Number: 00380650002365
• Catalog Number: 8065000236
• Company DUNS: 008018525
• Company Name: Alcon Laboratories, Inc.
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00380650002365 [Primary]
GS1	10380650002362 [Package]; Contains: 00380650002365; Package: Box [6 Units]; In Commercial Distribution

FDA Product Code

• HQF: Laser, Ophthalmic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-11
• Device Publish Date: 2024-07-03

On-Brand Devices [UNITY TETRASPOT]

• 10380650002379: 27GA TETRASPOT MultiSpot Laser Probe
• 10380650002362: 25GA TETRASPOT MultiSpot Laser Probe