25G PASSIVE ASP HP W/SOFT TIP 12B SUJ02

GUDID 24058935005461

Single Use Medical Device for Ophthalmic Surgery

Bausch & Lomb GmbH

Vitrectomy fluid/gas handling handpiece/cannula

• Primary Device ID: 24058935005461
• NIH Device Record Key: c17713fc-c0e9-46d2-8f3a-2d67d9f43e0e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 25G PASSIVE ASP HP W/SOFT TIP 12B
• Version Model Number: SUJ02
• Catalog Number: SUJ02
• Company DUNS: 344609518
• 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: 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	04058935005467 [Primary]
GS1	24058935005461 [Unit of Use]

FDA Product Code

• HMX: Cannula, Ophthalmic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-07-17
• Device Publish Date: 2023-09-12

Devices Manufactured by Bausch & Lomb GmbH

• 00405893501229 - Gills-Welsh-Vannas Capsulotomy Scissors: 2025-07-21
• 04058935011086 - Tissue Forceps: 2025-07-21
• 04058935011093 - Straight Dressing Forceps: 2025-07-21
• 04058935011109 - Curved Dressing Forceps: 2025-07-21
• 04058935011116 - Strong Curved Dressing Forceps: 2025-07-21
• 04058935011123 - Light Curved Dressing Forceps: 2025-07-21
• 04058935011130 - Bracken Iris Forceps: 2025-07-21
• 04058935011147 - Straight Tissue Forceps: 2025-07-21