Bipolar Pencil Tapered E7920

GUDID 04058935000660

Medical Device for Ophthalmic Surgery

Bausch & Lomb GmbH

Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

• Primary Device ID: 04058935000660
• NIH Device Record Key: 20a8f818-c8b7-4bde-bd53-b00151fbad04
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bipolar Pencil Tapered
• Version Model Number: E7920
• Catalog Number: E7920
• Company DUNS: 342397433
• Company Name: Bausch & Lomb GmbH
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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	04058935000660 [Primary]

FDA Product Code

• GXI: Probe, Radiofrequency Lesion

Sterilization

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

[04058935000660]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-10-29
• Device Publish Date: 2016-07-15

Devices Manufactured by Bausch & Lomb GmbH

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• 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