Single Use Electrosurgical Knife N1083531

GUDID 14953170462334

OLYMPUS MEDICAL SYSTEMS CORP.

Endoscopic electrosurgical handpiece/electrode, monopolar, single-use

• Primary Device ID: 14953170462334
• NIH Device Record Key: 3bb4792c-57b3-49af-8fff-556f93b1d978
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Single Use Electrosurgical Knife
• Version Model Number: KD-630L
• Catalog Number: N1083531
• Company DUNS: 711789789
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• 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: false
• 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

Customer Support Contacts

• Phone: +1(800)401-1086
• Email: xx@xx.xx
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170462337 [Primary]
GS1	14953170462334 [Package]; Contains: 04953170462337; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092309

FDA Product Code

• KNS: Unit, Electrosurgical, Endoscopic (With Or Without 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: 2024-04-02
• Device Publish Date: 2024-03-25

On-Brand Devices [Single Use Electrosurgical Knife]

• 14953170251518: KD-620UR
• 14953170251501: KD-620QR
• 14953170225960: Single Use Electrosurgical Knife
• 14953170208543: KD-610L
• 14953170208420: Single Use Electrosurgical Knife
• 14953170208413: KD-630L
• 14953170208406: Single Use Electrosurgical Knife
• 14953170453967: KD-620UR
• 14953170453950: KD-620QR
• 14953170453943: KD-620LR
• 14953170462334: KD-630L