Spetzler™ Lighted Suction Tube, 5 French, 160mm long

GUDID 10817489025250

Spetzler™ Lighted Suction Tube, 5 French, 160mm long

KATALYST SURGICAL LLC

Surgical/emergency suction cannula, illuminating, single-use

• Primary Device ID: 10817489025250
• NIH Device Record Key: cb438a41-8176-4d83-8704-7484b9ee8eef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spetzler™ Lighted Suction Tube, 5 French, 160mm long
• Version Model Number: DN1505-160
• 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: 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	00817489025253 [Unit of Use]
GS1	10817489025250 [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: 2017-08-09

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