23ga Endo-Ocular Probes Steerable, Iridex Compatible

GUDID 00817489024393

Box of 10, 23ga Endo-Ocular Probes Steerable, Iridex Compatible

KATALYST SURGICAL LLC

Ophthalmic fibreoptic light instrument, single-use Ophthalmic fibreoptic light instrument, single-use Ophthalmic fibreoptic light instrument, single-use

• Primary Device ID: 00817489024393
• NIH Device Record Key: 54843c8a-2e68-4b03-b7bf-b829f8b36237
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 23ga Endo-Ocular Probes Steerable, Iridex Compatible
• Version Model Number: XLEND23DIRA
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817489024393 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121187

FDA Product Code

• HQF: Laser, 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: 4
• Public Version Date: 2019-05-07
• Device Publish Date: 2016-09-22

Devices Manufactured by KATALYST SURGICAL LLC

• 00840096215168 - 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
• 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
• 00840096215144 - Lanzino Forceps Set: 2023-12-15 Lanzino Forceps Set
• 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
• 00840096214871 - Stainless Steel Trocar Footplate SP = 100° Angle of Footplate; Overall Length 4.: 2023-08-04 Stainless Steel Trocar Footplate SP = 100° Angle of Footplate; Overall Length 4.625