CONSTELLATION® HYPERVIT® TOTAL PLUS®

GUDID 10380650000962

27+®Ga HYPERVIT® Bevel 20K CPM TOTAL PLUS® Combined Procedure Pak

Alcon Laboratories, Inc.

Ophthalmic surgical procedure kit, non-medicated, single-use

• Primary Device ID: 10380650000962
• NIH Device Record Key: 480ec6ff-910a-43fb-82bf-def46bcdca01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CONSTELLATION® HYPERVIT® TOTAL PLUS®
• Version Model Number: 8065000096
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00380650000965 [Primary]
GS1	10380650000962 [Package]; Contains: 00380650000965; Package: [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170520

FDA Product Code

• MLZ: Vitrectomy, instrument cutter

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: 2020-12-21
• Device Publish Date: 2020-12-11

On-Brand Devices [CONSTELLATION® HYPERVIT® TOTAL PLUS®]

• 10380658300774: 25+®Ga HYPERVIT® Bevel 20K CPM Wide TOTAL PLUS® Vitrectomy Pak
• 10380657531094: 27+®Ga HYPERVIT® Bevel 20K CPM TOTAL PLUS® Vitrectomy Pak
• 10380657531063: 25+®Ga HYPERVIT® Bevel 20K CPM TOTAL PLUS® Vitrectomy Pak
• 10380650000962: 27+®Ga HYPERVIT® Bevel 20K CPM TOTAL PLUS® Combined Procedure Pak
• 10380650000955: 25+®Ga HYPERVIT® Bevel 20K CPM TOTAL PLUS® Combined Procedure Pak