Spetzler Lighted Suction Tube, 5 French, 120mm, Storz Connector

GUDID 10856312006042

Spetzler Lighted Suction Tube, 5 French, 120mm, Storz Connector

KATALYST SURGICAL LLC

Surgical/emergency suction cannula, illuminating, single-use

• Primary Device ID: 10856312006042
• NIH Device Record Key: 8d725a1f-685a-4b53-a05b-fafec5eae6fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spetzler Lighted Suction Tube, 5 French, 120mm, Storz Connector
• Version Model Number: DN1405-120
• Company DUNS: 007883297
• Company Name: KATALYST SURGICAL LLC
• Device Count: 5
• 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: false
• 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	00856312006045 [Unit of Use]
GS1	10856312006042 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141781

FDA Product Code

• FST: Light, Surgical, Fiberoptic

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: 2020-04-20
• Device Publish Date: 2016-07-18

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