PPT MICS 6/BX PPT049

GUDID 04058935000646

Single Use Medical Device for Ophthalmic Surgery

Bausch & Lomb GmbH

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

• Primary Device ID: 04058935000646
• NIH Device Record Key: 9dac865c-777c-467f-a0b5-4737c9f10de7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PPT MICS 6/BX
• Version Model Number: PPT049
• Catalog Number: PPT049
• Company DUNS: 342397433
• Company Name: Bausch & Lomb GmbH
• Device Count: 6
• 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	04058935000646 [Primary]
GS1	24058935000640 [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

• 24058935003450 - 23G ENDGRIPPING FORCEPS 12/BX: 2024-07-17 Single Use Medical Device for Ophthalmic Surgery
• 24058935003474 - 25G ENDGRIPPING FORCEPS 12/BX: 2024-07-17 Single Use Medical Device for Ophthalmic Surgery
• 24058935004945 - CAPSULORHEXIS FORCEPS 12/BOX: 2024-07-17 Single Use Medical Device for Ophthalmic Surgery
• 24058935004969 - BONN FORCEPS 12/BOX: 2024-07-17 Single Use Medical Device for Ophthalmic Surgery
• 24058935004983 - TYING FORCEPS STRAIGHT 12/BOX: 2024-07-17 Single Use Medical Device for Ophthalmic Surgery
• 24058935005003 - MCPHERSON TYING FORCEPS 12/BOX: 2024-07-17 Single Use Medical Device for Ophthalmic Surgery
• 24058935005027 - PIERSE TYING FORCEPS 12/BOX: 2024-07-17 Single Use Medical Device for Ophthalmic Surgery
• 24058935005041 - MICS CAPSULORHEXIS FORCEPS 12/BOX: 2024-07-17 Single Use Medical Device for Ophthalmic Surgery