PROVISC

GUDID 00380651830851

PROVISC 0.85ML 27G

Alcon Laboratories, Inc.

Aqueous/vitreous humour replacement medium kit

• Primary Device ID: 00380651830851
• NIH Device Record Key: 4b2c3d49-e22d-4c90-89e4-518050fa8d7c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROVISC
• Version Model Number: 8065183085
• 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: false
• 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

Customer Support Contacts

• Phone: +1(800)-862-5266
• Email: web.masterus@alcon.com

Device Dimensions

• Total Volume: 0.85 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00380651830851 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P890047

FDA Product Code

• LZP: Aid, Surgical, Viscoelastic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-05-06
• Device Publish Date: 2015-03-31

On-Brand Devices [PROVISC]

• 00380651830851: PROVISC 0.85ML 27G
• 00380651830554: PROVISC 0.55ML 27G
• 00380651830042: PROVISC 0.40ML 27G