25ga Maeno-Awh Super Manipulator

GUDID 10817489027278

25ga Maeno-Awh Super Manipulator

KATALYST SURGICAL LLC

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

• Primary Device ID: 10817489027278
• NIH Device Record Key: 5d18364c-48d0-48bb-80ea-233562f6b2c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 25ga Maeno-Awh Super Manipulator
• Version Model Number: DV1030-25
• Company DUNS: 007883297
• Company Name: KATALYST SURGICAL LLC
• Device Count: 5
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817489027271 [Unit of Use]
GS1	10817489027278 [Primary]

FDA Product Code

• MXY: Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-10-07
• Device Publish Date: 2018-05-22

Devices Manufactured by KATALYST SURGICAL LLC

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• 00840096215175 - GemcisionTM Paracentesis, Super Sharp, Sharp Sides, Straight Blade Housing, 1.2m: 2024-02-20 GemcisionTM Paracentesis, Super Sharp, Sharp Sides, Straight Blade Housing, 1.2mm Width
• 10840096215165 - GemcisionTM Paracentesis, Super Sharp, Sharp Sides, Straight Blade Housing, Trun: 2024-02-20 GemcisionTM Paracentesis, Super Sharp, Sharp Sides, Straight Blade Housing, Truncated, 1.0mm Width/Box of 5
• 10840096215172 - GemcisionTM Paracentesis, Super Sharp, Sharp Sides, Straight Blade Housing, 1.2m: 2024-02-20 GemcisionTM Paracentesis, Super Sharp, Sharp Sides, Straight Blade Housing, 1.2mm Width/Box of 5
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• 00840096215151 - Spetzler® Micro Dissection Set, Tray #3: 2023-12-15 Spetzler® Micro Dissection Set, Tray #3
• 00840096215137 - 27ga Dunn/Rice ILM Pick, Carbon Fiber Handle, Blunt: 2023-10-24 27ga Dunn/Rice ILM Pick, Carbon Fiber Handle, Blunt
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