IRR. HANDPIECE SMOOTH 12/BX 85787ST

GUDID 04058935000134

Single Use Medical Device for Ophthalmic Surgery

Bausch & Lomb GmbH

Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

• Primary Device ID: 04058935000134
• NIH Device Record Key: 359d25bb-1f39-4bed-8453-2df7ea6140c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IRR. HANDPIECE SMOOTH 12/BX
• Version Model Number: 85787ST
• Catalog Number: 85787ST
• Company DUNS: 342397433
• Company Name: Bausch & Lomb GmbH
• Device Count: 12
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04058935000134 [Primary]
GS1	24058935000138 [Unit of Use]

FDA Product Code

• HQC: Unit, Phacofragmentation

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-10-07
• 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: 2019-11-08 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