PPT CRYSTALENS 12/BX PPT051

GUDID 04058935000653

Single Use Medical Device for Ophthalmic Surgery

Bausch & Lomb GmbH

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

• Primary Device ID: 04058935000653
• NIH Device Record Key: b272d403-c1cd-43b7-91ee-47bd8dffea44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PPT CRYSTALENS 12/BX
• Version Model Number: PPT051
• Catalog Number: PPT051
• Company DUNS: 342397433
• Company Name: Bausch & Lomb GmbH
• Device Count: 12
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	04058935000653 [Primary]
GS1	24058935000657 [Unit of Use]

FDA Product Code

• OJK: Eye Tray

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-07-15

Devices Manufactured by Bausch & Lomb GmbH

• 04058935000646 - PPT MICS 6/BX: 2019-11-08 Single Use Medical Device for Ophthalmic Surgery
• 04058935000653 - PPT CRYSTALENS 12/BX: 2019-11-08Single Use Medical Device for Ophthalmic Surgery
• 04058935000653 - PPT CRYSTALENS 12/BX: 2019-11-08 Single Use Medical Device for Ophthalmic Surgery
• 04058935000011 - SIL I/A HANDP CURVED STELL 12/B: 2019-10-07 Single Use Medical Device for Ophthalmic Surgery
• 04058935000028 - ASP HANDPIECE STERILE 12/BOX: 2019-10-07 Single Use Medical Device for Ophthalmic Surgery
• 04058935000035 - IRR HANDPIECE STERILE 12/BOX: 2019-10-07 Single Use Medical Device for Ophthalmic Surgery
• 04058935000042 - I/A HANDP.STRAIGHT,17G 12/BOX: 2019-10-07 Single Use Medical Device for Ophthalmic Surgery
• 04058935000059 - I/A HANDP.CURVED,17G 12/BOX: 2019-10-07 Single Use Medical Device for Ophthalmic Surgery
• 04058935000066 - I/A HANDPIECE CURVED 17G 12/B: 2019-10-07 Single Use Medical Device for Ophthalmic Surgery