Spetzler Lighted Suction Tube, 7 French 160mm, Storz Connector

GUDID 10856312006097

Spetzler Lighted Suction Tube, 7 French 160mm, Storz Connector

KATALYST SURGICAL LLC

Surgical/emergency suction cannula, illuminating, single-use

• Primary Device ID: 10856312006097
• NIH Device Record Key: 24b95cd7-d094-4d3b-aa7f-f6c6b6f9a62b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spetzler Lighted Suction Tube, 7 French 160mm, Storz Connector
• Version Model Number: DN1407-160
• 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	00856312006090 [Unit of Use]
GS1	10856312006097 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141781

FDA Product Code

• HBI: Illuminator, Fiberoptic, Surgical Field

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

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• 00840096215212 - Straight Forceps, 0.5mmTips, Interlocking 1x2 Teeth, Round Handle, 180mm| Kogent: 2024-06-26 Straight Forceps, 0.5mmTips, Interlocking 1x2 Teeth, Round Handle, 180mm | Kogent
• 00840096215229 - Straight Forceps, 0.5mmTips, Interlocking 1x2 Teeth,Bayonet, Round Handle, 210mm: 2024-06-26 Straight Forceps, 0.5mmTips, Interlocking 1x2 Teeth, Bayonet, Round Handle, 210mm | Kogent
• 00840096215236 - Straight Forceps,0.3mm Tips, Interlocking 1x2 Teeth, Bayonet,Round Handle, 210mm: 2024-06-26 Straight Forceps, 0.3mm Tips, Interlocking 1x2 Teeth, Bayonet, Round Handle, 210mm | Kogent