Beaver-Visitec MMK834/1

GUDID 05055186235833

Malosa Core Phaco Pack 2 (30/SP)

Beaver-Visitec International, Inc.

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

• Primary Device ID: 05055186235833
• NIH Device Record Key: a5ce633f-ed22-4a92-9475-f77660f92dc1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Beaver-Visitec
• Version Model Number: MMK834/1
• Catalog Number: MMK834/1
• Company DUNS: 001406024
• Company Name: Beaver-Visitec International, Inc.
• Device Count: 30
• 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: 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	05055186235833 [Unit of Use]
GS1	35055186235834 [Primary]

FDA Product Code

• PZG: Surgical Eye Tray

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: 2021-11-23
• Device Publish Date: 2021-11-15

On-Brand Devices [Beaver-Visitec]

• 05055186237981: Malosa Core Phaco Pack 1 (30/SP)
• 05055186236953: Malosa Core SMILE Pack 1 (20/SP)
• 05055186236069: Malosa Core Suface Treatment Pack (20/SP)
• 05055186236052: Malosa Core LASIK Pack 2 (20/SP)
• 05055186235833: Malosa Core Phaco Pack 2 (30/SP)
• 05055186240066: Malosa Core SMILE Pack 2-Beaver-Visitec International Ltd (30/SP)