Ngenuity

GUDID 00380657530915

Microsurgical Camera

Alcon Laboratories, Inc.

Microscope video camera

• Primary Device ID: 00380657530915
• NIH Device Record Key: 0a281b5f-fd75-4ea4-93f2-e73083d84b8b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ngenuity
• Version Model Number: 00380657530915
• Company DUNS: 008018525
• Company Name: Alcon Laboratories, Inc.
• 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	00380657530915 [Primary]

FDA Product Code

• FWJ: CAMERA, CINE, MICROSURGICAL, WITHOUT AUDIO

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: 2022-10-06
• Device Publish Date: 2022-09-28

On-Brand Devices [Ngenuity]

• 00380657530915: Microsurgical Camera
• 00380650001139: Microsurgical Camera