XLEND25MULTIFLEX

GUDID 10840096215318

MULTIFLEX LASER PROBE 25ga Quantel Compatible

KATALYST SURGICAL LLC

Ophthalmic laser system beam guide

• Primary Device ID: 10840096215318
• NIH Device Record Key: 3206545d-ab22-44c1-9ca6-d78c2120b817
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XLEND25MULTIFLEX
• Version Model Number: XLEND25MULTIFLEX
• Company DUNS: 007883297
• Company Name: KATALYST SURGICAL LLC
• 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: 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	00840096215311 [Primary]
GS1	10840096215318 [Package]; Contains: 00840096215311; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121187

FDA Product Code

• HQB: Photocoagulator And Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-02
• Device Publish Date: 2025-06-24

Devices Manufactured by KATALYST SURGICAL LLC

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• 10840096215318 - XLEND25MULTIFLEX: 2025-07-02MULTIFLEX LASER PROBE 25ga Quantel Compatible
• 10840096215318 - XLEND25MULTIFLEX: 2025-07-02 MULTIFLEX LASER PROBE 25ga Quantel Compatible
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• 00840096206357 - 23ga ISOCLEAN™ Serrated Forceps, Straight Shaft, Gold: 2025-04-04 23ga ISOCLEAN™ Serrated Forceps, Straight Shaft, Gold
• 00840096208344 - ISOCLEAN™ Johnston Extractor Forceps: 2025-04-04 ISOCLEAN™ Johnston Extractor Forceps